FDA — authorised 4 September 1958
- Marketing authorisation holder: OAK PHARMS AKORN
- Status: approved
🇺🇸 Diuril in United States
FDA authorised Diuril on 4 September 1958
Marketing authorisations
FDA — authorised 11 December 1958
- Application: NDA011635
- Marketing authorisation holder: MERCK
- Local brand name: DIUPRES-250
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1968
- Application: NDA016016
- Marketing authorisation holder: MERCK
- Local brand name: ALDOCLOR-150
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1975
- Application: ANDA084217
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 1977
- Application: ANDA085173
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 1978
- Application: ANDA085569
- Marketing authorisation holder: ABC HOLDING
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 1981
- Application: ANDA085485
- Marketing authorisation holder: SANDOZ
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1982
- Application: ANDA087745
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLOROTHIAZIDE-RESERPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1982
- Application: ANDA087744
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLOROTHIAZIDE-RESERPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1982
- Application: ANDA087736
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1982
- Application: ANDA086028
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 1982
- Application: ANDA086940
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 1982
- Application: ANDA086938
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 1983
- Application: ANDA086795
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 1983
- Application: ANDA088557
- Marketing authorisation holder: HIKMA
- Local brand name: CHLOROTHIAZIDE AND RESERPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 1983
- Application: ANDA088365
- Marketing authorisation holder: HIKMA
- Local brand name: CHLOROTHIAZIDE AND RESERPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 1995
- Application: NDA011870
- Marketing authorisation holder: SALIX PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 26 July 2011
- Application: ANDA091546
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 22 April 2013
- Application: ANDA202561
- Marketing authorisation holder: AM REGENT
- Status: approved
FDA — authorised 29 May 2015
- Application: ANDA202462
- Marketing authorisation holder: SAGENT PHARMS INC
- Status: approved
FDA — authorised 3 October 2024
- Application: ANDA218630
- Marketing authorisation holder: GLAND
- Status: approved
FDA
- Application: ANDA084026
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085165
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086796
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070783
- Marketing authorisation holder: PAR PHARM
- Local brand name: METHYLDOPA AND CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070654
- Marketing authorisation holder: PAR PHARM
- Local brand name: METHYLDOPA AND CHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
Diuril in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Diuril approved in United States?
Yes. FDA authorised it on 4 September 1958; FDA authorised it on 11 December 1958; FDA authorised it on 20 March 1968.
Who is the marketing authorisation holder for Diuril in United States?
OAK PHARMS AKORN holds the US marketing authorisation.