FDA — authorised 24 February 1960
- Marketing authorisation holder: VALEANT PHARM INTL
- Status: approved
🇺🇸 Chlordiazepoxide Hydrochloride in United States
FDA authorised Chlordiazepoxide Hydrochloride on 24 February 1960
Marketing authorisations
FDA — authorised 24 February 1960
- Application: NDA012249
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 September 1966
- Application: NDA012750
- Marketing authorisation holder: BAUSCH
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 7 March 1975
- Application: ANDA083570
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 February 1976
- Application: ANDA084623
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 February 1976
- Application: ANDA084644
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 February 1976
- Application: ANDA084645
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1976
- Application: ANDA085108
- Marketing authorisation holder: ALRA
- Local brand name: LYGEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1976
- Application: ANDA085009
- Marketing authorisation holder: ALRA
- Local brand name: LYGEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1976
- Application: ANDA085107
- Marketing authorisation holder: ALRA
- Local brand name: LYGEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 1976
- Application: ANDA084639
- Marketing authorisation holder: RACHELLE
- Local brand name: CHLORDIAZACHEL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 1976
- Application: ANDA085086
- Marketing authorisation holder: RACHELLE
- Local brand name: CHLORDIAZACHEL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 1976
- Application: ANDA085087
- Marketing authorisation holder: RACHELLE
- Local brand name: CHLORDIAZACHEL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 June 1976
- Application: ANDA084768
- Marketing authorisation holder: BARR
- Status: approved
FDA — authorised 15 June 1976
- Application: ANDA084678
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 June 1976
- Application: ANDA084041
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 June 1976
- Application: ANDA084679
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 July 1976
- Application: ANDA084706
- Marketing authorisation holder: ROXANE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 July 1976
- Application: ANDA084700
- Marketing authorisation holder: ROXANE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 August 1976
- Application: ANDA085164
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 August 1976
- Application: ANDA085163
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 August 1976
- Application: ANDA084598
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 1976
- Application: ANDA085119
- Marketing authorisation holder: FERRANTE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 1976
- Application: ANDA085120
- Marketing authorisation holder: FERRANTE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 1977
- Application: ANDA085000
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 1977
- Application: ANDA085014
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 1977
- Application: ANDA085513
- Marketing authorisation holder: ABBOTT
- Local brand name: A-POXIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 July 1977
- Application: ANDA085518
- Marketing authorisation holder: ABBOTT
- Local brand name: A-POXIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 July 1977
- Application: ANDA085517
- Marketing authorisation holder: ABBOTT
- Local brand name: A-POXIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 September 1977
- Application: ANDA085461
- Marketing authorisation holder: BAUSCH
- Local brand name: LIBRIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 September 1977
- Application: ANDA085475
- Marketing authorisation holder: BAUSCH
- Local brand name: LIBRIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 September 1977
- Application: ANDA085472
- Marketing authorisation holder: BAUSCH
- Local brand name: LIBRIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 December 1977
- Application: ANDA085113
- Marketing authorisation holder: IMPAX LABS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 September 1978
- Application: ANDA086383
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 September 1978
- Application: ANDA086382
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 February 1981
- Application: ANDA086494
- Marketing authorisation holder: TEVA
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 1981
- Application: ANDA085118
- Marketing authorisation holder: FERRANTE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 1982
- Application: ANDA084601
- Marketing authorisation holder: MYLAN
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 May 1982
- Application: ANDA087037
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 January 1983
- Application: ANDA084705
- Marketing authorisation holder: ROXANE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 March 1983
- Application: ANDA088010
- Marketing authorisation holder: VANGARD
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 June 1983
- Application: ANDA087525
- Marketing authorisation holder: ASCOT
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 June 1983
- Application: ANDA087524
- Marketing authorisation holder: ASCOT
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 June 1983
- Application: ANDA087512
- Marketing authorisation holder: ASCOT
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 September 1983
- Application: NDA017813
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRELEASE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 June 1984
- Application: ANDA087231
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 June 1984
- Application: ANDA087234
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 April 1985
- Application: ANDA088986
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 April 1985
- Application: ANDA088988
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 April 1985
- Application: ANDA088987
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 1986
- Application: ANDA084769
- Marketing authorisation holder: BARR
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 1 December 1998
- Application: ANDA083116
- Marketing authorisation holder: BARR
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 7 July 2020
- Application: ANDA211421
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 October 2020
- Application: ANDA213530
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 April 2021
- Application: ANDA214065
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 May 2021
- Application: ANDA214698
- Marketing authorisation holder: DR REDDYS
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 October 2021
- Application: ANDA215555
- Marketing authorisation holder: AMNEAL
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 November 2021
- Application: ANDA211476
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2022
- Application: ANDA215835
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 14 September 2023
- Application: ANDA216419
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 September 2023
- Application: ANDA216969
- Marketing authorisation holder: ALEMBIC
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 December 2023
- Application: ANDA217385
- Marketing authorisation holder: TORRENT
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085155
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085481
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRITABS
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085482
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRITABS
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084685
- Marketing authorisation holder: HALSEY
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085144
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CHLORDIAZEPOXIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085447
- Marketing authorisation holder: ABBOTT
- Local brand name: A-POXIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085488
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRITABS
- Indication: TABLET — ORAL
- Status: approved
Chlordiazepoxide Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Chlordiazepoxide Hydrochloride approved in United States?
Yes. FDA authorised it on 24 February 1960; FDA authorised it on 24 February 1960; FDA authorised it on 1 September 1966.
Who is the marketing authorisation holder for Chlordiazepoxide Hydrochloride in United States?
VALEANT PHARM INTL holds the US marketing authorisation.