FDA — authorised 12 October 1984
- Application: NDA018709
- Marketing authorisation holder: APOTHECON
- Local brand name: CAPOZIDE 25/25
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ACE inhibitors in United States
FDA authorised ACE inhibitors on 12 October 1984 · 403 US adverse-event reports
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: ANDA074505
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074418
- Marketing authorisation holder: OXFORD PHARMS
- 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 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: ANDA074451
- Marketing authorisation holder: WATSON LABS
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074433
- Marketing authorisation holder: COSETTE
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074434
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: ANDA074423
- Marketing authorisation holder: DAVA PHARMS INC
- 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 23 May 1996
- Application: ANDA074386
- 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 May 1997
- Application: ANDA074748
- Marketing authorisation holder: EGIS PHARMS
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 1997
- Application: ANDA074677
- Marketing authorisation holder: ANDAS 5 HOLDING
- 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: ANDA074832
- Marketing authorisation holder: WATSON LABS
- 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 18 June 1998
- Application: ANDA075055
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 1998
- Application: ANDA074737
- Marketing authorisation holder: COREPHARMA
- Local brand name: CAPTOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2019
- Application: ANDA212223
- Marketing authorisation holder: SETON PHARMS
- Local brand name: CAPTOPRIL
- 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
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: 21 April 2025 – 21 April 2026
- Total reports: 403
Most-reported reactions
- Weight Increased — 104 reports (25.81%)
- Extrapyramidal Disorder — 63 reports (15.63%)
- Completed Suicide — 32 reports (7.94%)
- Nausea — 31 reports (7.69%)
- Pancreatitis — 31 reports (7.69%)
- Renal Failure Acute — 31 reports (7.69%)
- Dyspnoea — 29 reports (7.2%)
- Off Label Use — 28 reports (6.95%)
- Renal Failure — 28 reports (6.95%)
- Death — 26 reports (6.45%)
Other Cardiovascular approved in United States
Frequently asked questions
Is ACE inhibitors 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 ACE inhibitors in United States?
APOTHECON holds the US marketing authorisation.