FDA — authorised 23 August 1965
- Application: NDA014715
- Marketing authorisation holder: NEW RIVER
- Local brand name: TRIAVIL 2-25
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 AMITRIPTYLINE HYDROCHLORIDE in United States
FDA authorised AMITRIPTYLINE HYDROCHLORIDE on 23 August 1965 · 12,839 US adverse-event reports
Marketing authorisations
FDA — authorised 17 September 1969
- Application: NDA014713
- Marketing authorisation holder: SCHERING
- Local brand name: ETRAFON 2-10
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 1976
- Application: ANDA085031
- Marketing authorisation holder: ANI PHARMS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 1976
- Application: ANDA085032
- Marketing authorisation holder: ANI PHARMS INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1977
- Application: ANDA085627
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 1977
- Application: ANDA085744
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 1977
- Application: ANDA085745
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 1977
- Application: ANDA085743
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1977
- Application: ANDA085742
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1977
- Application: ANDA085944
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1977
- Application: ANDA085945
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 1977
- Application: ANDA086004
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 1977
- Application: ANDA086002
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 1977
- Application: ANDA086003
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 1977
- Application: ANDA086090
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 1977
- Application: ANDA085970
- Marketing authorisation holder: SANDOZ
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 1977
- Application: ANDA085968
- Marketing authorisation holder: SANDOZ
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1977
- Application: NDA016949
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LIMBITROL DS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1978
- Application: ANDA086145
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1978
- Application: ANDA086148
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1978
- Application: ANDA086143
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1978
- Application: ANDA086144
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1978
- Application: ANDA086147
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1978
- Application: ANDA086146
- Marketing authorisation holder: ROXANE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 1978
- Application: ANDA086010
- Marketing authorisation holder: MYLAN
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 1978
- Application: ANDA086011
- Marketing authorisation holder: MYLAN
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 1978
- Application: ANDA086009
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 1978
- Application: ANDA086153
- Marketing authorisation holder: MYLAN
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 1978
- Application: ANDA086157
- Marketing authorisation holder: MYLAN
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 1978
- Application: ANDA086158
- Marketing authorisation holder: MYLAN
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 1978
- Application: ANDA085815
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 1978
- Application: ANDA085816
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 1978
- Application: ANDA085817
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 1978
- Application: ANDA086454
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: AMITID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 1981
- Application: ANDA085925
- Marketing authorisation holder: HALSEY
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 1982
- Application: ANDA087632
- Marketing authorisation holder: VANGARD
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 1982
- Application: ANDA087617
- Marketing authorisation holder: VANGARD
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 1982
- Application: ANDA087616
- Marketing authorisation holder: VANGARD
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 1982
- Application: ANDA087639
- Marketing authorisation holder: VANGARD
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 1982
- Application: ANDA087775
- Marketing authorisation holder: USL PHARMA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 1982
- Application: ANDA086746
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 1983
- Application: ANDA085926
- Marketing authorisation holder: HALSEY
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 1983
- Application: ANDA085927
- Marketing authorisation holder: HALSEY
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1984
- Application: ANDA088622
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1984
- Application: ANDA088635
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1984
- Application: ANDA088634
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1984
- Application: ANDA088633
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1984
- Application: ANDA088620
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1984
- Application: ANDA088621
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 1984
- Application: ANDA088701
- Marketing authorisation holder: PAR PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 1984
- Application: ANDA088697
- Marketing authorisation holder: PAR PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 1984
- Application: ANDA088698
- Marketing authorisation holder: PAR PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 1984
- Application: ANDA088699
- Marketing authorisation holder: PAR PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 1984
- Application: ANDA088700
- Marketing authorisation holder: PAR PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 1984
- Application: ANDA088702
- Marketing authorisation holder: PAR PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088888
- Marketing authorisation holder: PLIVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088886
- Marketing authorisation holder: PLIVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088885
- Marketing authorisation holder: PLIVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088883
- Marketing authorisation holder: PLIVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088887
- Marketing authorisation holder: PLIVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088884
- Marketing authorisation holder: PLIVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 1985
- Application: ANDA087557
- Marketing authorisation holder: HALSEY
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 1985
- Application: ANDA087647
- Marketing authorisation holder: WEST WARD
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 1985
- Application: ANDA087278
- Marketing authorisation holder: WEST WARD
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 1986
- Application: ANDA071078
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 1986
- Application: ANDA071077
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 1986
- Application: ANDA070297
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 1986
- Application: ANDA071079
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1986
- Application: ANDA070765
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1986
- Application: ANDA070766
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1986
- Application: ANDA071296
- Marketing authorisation holder: MYLAN
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1986
- Application: ANDA071297
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA089423
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1987
- Application: ANDA071558
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1987
- Application: ANDA089399
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1987
- Application: ANDA089402
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1987
- Application: ANDA089400
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1987
- Application: ANDA071064
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1987
- Application: ANDA071062
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1987
- Application: ANDA071063
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 1987
- Application: ANDA071863
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 1987
- Application: ANDA071862
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 1988
- Application: ANDA072278
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 1988
- Application: ANDA072277
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 1988
- Application: ANDA070337
- Marketing authorisation holder: MYLAN
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 1988
- Application: ANDA070338
- Marketing authorisation holder: MYLAN
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 1988
- Application: ANDA070336
- Marketing authorisation holder: MYLAN
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 1988
- Application: ANDA071442
- Marketing authorisation holder: MYLAN
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 1988
- Application: ANDA071443
- Marketing authorisation holder: MYLAN
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1988
- Application: ANDA072053
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1988
- Application: ANDA072052
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1989
- Application: ANDA072134
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1989
- Application: ANDA072539
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1989
- Application: ANDA072540
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1989
- Application: ANDA072541
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1989
- Application: ANDA072135
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1991
- Application: ANDA073010
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1991
- Application: ANDA073007
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1991
- Application: ANDA073008
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1991
- Application: ANDA073009
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 1997
- Application: ANDA040218
- Marketing authorisation holder: PH HEALTH
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2008
- Application: ANDA040816
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 June 2014
- Application: ANDA202446
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2017
- Application: ANDA210086
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA212654
- Marketing authorisation holder: AIPING PHARM INC
- Status: supplemented
FDA — authorised 19 February 2021
- Application: ANDA213999
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2021
- Application: ANDA214548
- Marketing authorisation holder: UNICHEM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved AMITRIPTYLINE HYDROCHLORIDE for marketing by UNICHEM on 24 June 2025. The approval was granted under the standard expedited pathway. The application number for this approval is ANDA214548. The approved indication for AMITRIPTYLINE HYDROCHLORIDE is listed in the labelling.
FDA — authorised 2 February 2022
- Application: ANDA211925
- Marketing authorisation holder: MICRO LABS
- Indication: Labeling
- Status: approved
The FDA approved AMITRIPTYLINE HYDROCHLORIDE for marketing by MICRO LABS on 17 June 2025. This approval was granted through the standard expedited pathway. The drug's indication was approved for its labelling.
FDA — authorised 6 June 2022
- Application: ANDA216243
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Amitriptyline Hydrochloride, manufactured by Breckenridge, on 24 June 2025. This approval was granted under the standard expedited pathway. Amitriptyline Hydrochloride is indicated for use in the labelling approved by the FDA.
FDA — authorised 1 May 2023
- Application: ANDA215376
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2023
- Application: ANDA217411
- Marketing authorisation holder: RISING
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2025
- Application: ANDA218389
- Marketing authorisation holder: UNIQUE PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070376
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086744
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086743
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088675
- Marketing authorisation holder: AM THERAP
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088674
- Marketing authorisation holder: AM THERAP
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088673
- Marketing authorisation holder: AM THERAP
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088672
- Marketing authorisation holder: AM THERAP
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086610
- Marketing authorisation holder: TEVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070377
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085594
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070375
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087181
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070374
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070373
- Marketing authorisation holder: WATSON LABS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070477
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070478
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085093
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: AMITRIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088857
- Marketing authorisation holder: SUPERPHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088856
- Marketing authorisation holder: SUPERPHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088855
- Marketing authorisation holder: SUPERPHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085936
- Marketing authorisation holder: UCB INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088854
- Marketing authorisation holder: SUPERPHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085935
- Marketing authorisation holder: UCB INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088853
- Marketing authorisation holder: SUPERPHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070621
- Marketing authorisation holder: PAR PHARM
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070620
- Marketing authorisation holder: PAR PHARM
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070939
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088075
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070937
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070936
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088076
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086337
- Marketing authorisation holder: UCB INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088077
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086336
- Marketing authorisation holder: UCB INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088078
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088079
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085923
- Marketing authorisation holder: HALSEY
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088084
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088085
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083939
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: AMITRIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087366
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087367
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088421
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086853
- Marketing authorisation holder: TEVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087368
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088422
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086854
- Marketing authorisation holder: TEVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087369
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088423
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086857
- Marketing authorisation holder: TEVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087370
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088424
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086859
- Marketing authorisation holder: TEVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088425
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086860
- Marketing authorisation holder: TEVA
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088426
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086335
- Marketing authorisation holder: UCB INC
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083938
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: AMITRIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088105
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085922
- Marketing authorisation holder: HALSEY
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088106
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070938
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088107
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086747
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086745
- Marketing authorisation holder: LEDERLE
- Local brand name: AMITRIPTYLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 12,839
Most-reported reactions
- Pain — 1,658 reports (12.91%)
- Nausea — 1,474 reports (11.48%)
- Headache — 1,419 reports (11.05%)
- Fatigue — 1,404 reports (10.94%)
- Dyspnoea — 1,381 reports (10.76%)
- Dizziness — 1,183 reports (9.21%)
- Diarrhoea — 1,113 reports (8.67%)
- Fall — 1,092 reports (8.51%)
- Malaise — 1,085 reports (8.45%)
- Off Label Use — 1,030 reports (8.02%)
AMITRIPTYLINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is AMITRIPTYLINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 23 August 1965; FDA authorised it on 17 September 1969; FDA authorised it on 16 November 1976.
Who is the marketing authorisation holder for AMITRIPTYLINE HYDROCHLORIDE in United States?
NEW RIVER holds the US marketing authorisation.