FDA — authorised 8 May 1964
- Application: NDA015103
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: DEMI-REGROTON
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 HGP1405 in United States
FDA authorised HGP1405 on 8 May 1964
Marketing authorisations
FDA — authorised 26 February 1981
- Application: ANDA086831
- Marketing authorisation holder: MYLAN
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 1981
- Application: ANDA087292
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 1981
- Application: ANDA087293
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1981
- Application: ANDA087384
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1981
- Application: ANDA087364
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 1981
- Application: ANDA087311
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 1981
- Application: ANDA087312
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1981
- Application: ANDA087176
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 1981
- Application: ANDA087381
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 1981
- Application: ANDA087555
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1981
- Application: ANDA087521
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1981
- Application: ANDA087296
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1981
- Application: ANDA087100
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1981
- Application: ANDA087082
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA087706
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA087689
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1982
- Application: ANDA088012
- Marketing authorisation holder: VANGARD
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1982
- Application: ANDA087118
- Marketing authorisation holder: SANDOZ
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1983
- Application: ANDA087247
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1983
- Application: ANDA088073
- Marketing authorisation holder: VANGARD
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1984
- Application: ANDA087947
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1984
- Application: ANDA088051
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: THALITONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 1985
- Application: ANDA088651
- Marketing authorisation holder: COSETTE
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1985
- Application: ANDA088902
- Marketing authorisation holder: BARR LABS INC
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1985
- Application: ANDA088903
- Marketing authorisation holder: BARR LABS INC
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 1986
- Application: ANDA089286
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 1986
- Application: ANDA089285
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1987
- Application: ANDA071325
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: CLORPRES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1987
- Application: ANDA071179
- Marketing authorisation holder: PAR PHARM
- Local brand name: CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1987
- Application: ANDA071142
- Marketing authorisation holder: PAR PHARM
- Local brand name: CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1987
- Application: ANDA071178
- Marketing authorisation holder: PAR PHARM
- Local brand name: CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2017
- Application: ANDA206904
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 2018
- Application: ANDA207222
- Marketing authorisation holder: UMEDICA
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 October 2018
- Application: ANDA210742
- Marketing authorisation holder: APPCO
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2019
- Application: ANDA211063
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2019
- Application: ANDA207813
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2019
- Application: ANDA207204
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2020
- Application: ANDA213412
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2020
- Application: ANDA214129
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2022
- Application: ANDA209068
- Marketing authorisation holder: SUNNY
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2022
- Application: ANDA211320
- Marketing authorisation holder: INVENTIA
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2022
- Application: ANDA212878
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2022
- Application: ANDA212875
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2022
- Application: ANDA215587
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2022
- Application: ANDA216262
- Marketing authorisation holder: ALEMBIC
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2024
- Application: ANDA209162
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2025
- Application: NDA218647
- Marketing authorisation holder: PRM PHARMA
- Local brand name: HEMICLOR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087050
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089051
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089052
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087516
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087698
- Marketing authorisation holder: ASCOT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089739
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087029
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088140
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089738
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088139
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA019451
- Marketing authorisation holder: NOVARTIS
- Local brand name: LOPRESSIDONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087699
- Marketing authorisation holder: ASCOT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089591
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087515
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is HGP1405 approved in United States?
Yes. FDA authorised it on 8 May 1964; FDA authorised it on 26 February 1981; FDA authorised it on 5 March 1981.
Who is the marketing authorisation holder for HGP1405 in United States?
SANOFI AVENTIS US holds the US marketing authorisation.