🇺🇸 HYDRALAZINE in United States

FDA authorised HYDRALAZINE on 21 April 1978 · 20,762 US adverse-event reports

Marketing authorisations

FDA — authorised 21 April 1978

  • Application: ANDA085771
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 December 1985

  • Application: ANDA089097
  • Marketing authorisation holder: PLIVA
  • Status: supplemented

FDA — authorised 18 December 1985

  • Application: ANDA089098
  • Marketing authorisation holder: PLIVA
  • Status: approved

FDA — authorised 26 February 2010

  • Application: ANDA040858
  • Marketing authorisation holder: HERITAGE PHARMS INC
  • Status: approved

FDA — authorised 18 September 2014

  • Application: ANDA203845
  • Marketing authorisation holder: CADILA PHARMS LTD
  • Status: supplemented

FDA — authorised 17 July 2025

  • Application: ANDA219797
  • Marketing authorisation holder: BAXTER HLTHCARE CORP
  • Status: approved

FDA

  • 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.

Most-reported reactions

  1. Chronic Kidney Disease — 2,919 reports (14.06%)
  2. Acute Kidney Injury — 2,753 reports (13.26%)
  3. Renal Failure — 2,390 reports (11.51%)
  4. Dyspnoea — 2,084 reports (10.04%)
  5. Fatigue — 2,038 reports (9.82%)
  6. Diarrhoea — 1,851 reports (8.92%)
  7. Nausea — 1,765 reports (8.5%)
  8. Death — 1,723 reports (8.3%)
  9. End Stage Renal Disease — 1,632 reports (7.86%)
  10. Hypertension — 1,607 reports (7.74%)

Source database →

HYDRALAZINE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is HYDRALAZINE approved in United States?

Yes. FDA authorised it on 21 April 1978; FDA authorised it on 18 December 1985; FDA authorised it on 18 December 1985.

Who is the marketing authorisation holder for HYDRALAZINE in United States?

WATSON LABS holds the US marketing authorisation.