FDA — authorised 7 May 1980
- Application: ANDA087108
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Spironolactone Oral Tablet in United States
FDA authorised Spironolactone Oral Tablet on 7 May 1980 · 11 US adverse-event reports
Marketing authorisations
FDA — authorised 28 January 1981
- Application: ANDA087265
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 1981
- Application: ANDA087086
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 1981
- Application: ANDA087078
- Marketing authorisation holder: WATSON LABS
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 1982
- Application: ANDA087648
- Marketing authorisation holder: VANGARD
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1982
- Application: ANDA087634
- Marketing authorisation holder: LEDERLE
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 1983
- Application: ANDA087687
- Marketing authorisation holder: ASCOT
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 1999
- Application: ANDA040353
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2010
- Application: ANDA091426
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 2014
- Application: ANDA202187
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2014
- Application: ANDA203253
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2017
- Application: NDA209478
- Marketing authorisation holder: CMP DEV LLC
- Local brand name: CAROSPIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 July 2018
- Application: ANDA205936
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2023
- Application: ANDA215572
- Marketing authorisation holder: AMNEAL
- Local brand name: SPIRONOLACTONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 January 2025
- Application: ANDA219494
- Marketing authorisation holder: GRAVITI PHARMS
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2025
- Application: ANDA217761
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087952
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087554
- Marketing authorisation holder: UPSHER SMITH
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA087998
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: SPIRONOLACTONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089364
- Marketing authorisation holder: SUPERPHARM
- Local brand name: SPIRONOLACTONE
- 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: 20 April 2025 – 20 April 2026
- Total reports: 11
Most-reported reactions
- Fatigue — 2 reports (18.18%)
- Abdominal Pain Upper — 1 report (9.09%)
- Back Pain — 1 report (9.09%)
- Dry Mouth — 1 report (9.09%)
- Dry Throat — 1 report (9.09%)
- Dyspepsia — 1 report (9.09%)
- Dysphonia — 1 report (9.09%)
- Fall — 1 report (9.09%)
- Full Blood Count Decreased — 1 report (9.09%)
- Headache — 1 report (9.09%)
Spironolactone Oral Tablet 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 Spironolactone Oral Tablet approved in United States?
Yes. FDA authorised it on 7 May 1980; FDA authorised it on 28 January 1981; FDA authorised it on 3 February 1981.
Who is the marketing authorisation holder for Spironolactone Oral Tablet in United States?
IVAX PHARMS holds the US marketing authorisation.