FDA — authorised 12 October 1984
- Application: NDA018709
- Marketing authorisation holder: APOTHECON
- Local brand name: CAPOZIDE 25/15
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Capozide 25/15 in United States
FDA authorised Capozide 25/15 on 12 October 1984
Marketing authorisations
FDA — authorised 9 November 1995
- Application: ANDA074363
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074477
- Marketing authorisation holder: PRINSTON INC
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074505
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074519
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074322
- Marketing authorisation holder: TEVA
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 1996
- Application: ANDA074576
- Marketing authorisation holder: WATSON LABS
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 1996
- Application: ANDA074590
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 1997
- Application: ANDA074532
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1997
- Application: ANDA074896
- Marketing authorisation holder: RISING
- Local brand name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1997
- Application: ANDA074827
- Marketing authorisation holder: COSETTE
- Local brand name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1997
- Application: ANDA074832
- Marketing authorisation holder: WATSON LABS
- Local brand name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2019
- Application: ANDA212809
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2023
- Application: ANDA214442
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA074640
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
Capozide 25/15 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 Capozide 25/15 approved in United States?
Yes. FDA authorised it on 12 October 1984; FDA authorised it on 9 November 1995; FDA authorised it on 13 February 1996.
Who is the marketing authorisation holder for Capozide 25/15 in United States?
APOTHECON holds the US marketing authorisation.