FDA — authorised 20 April 1984
- Application: NDA018858
- Marketing authorisation holder: RISING
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Indomethacin suppository in United States
FDA authorised Indomethacin suppository on 20 April 1984 · 20 US adverse-event reports
Marketing authorisations
FDA — authorised 4 May 1984
- Application: NDA018730
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 May 1984
- Application: NDA018851
- Marketing authorisation holder: HERITAGE
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 August 1984
- Application: NDA018829
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 September 1985
- Application: ANDA070624
- Marketing authorisation holder: RISING
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 October 1985
- Application: ANDA070327
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 October 1985
- Application: ANDA070326
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA070719
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA070756
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 March 1986
- Application: ANDA070651
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 October 1986
- Application: ANDA070068
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 October 1986
- Application: ANDA070067
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 October 1986
- Application: ANDA070488
- Marketing authorisation holder: SUPERPHARM
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 March 1987
- Application: ANDA071412
- Marketing authorisation holder: HIKMA
- Local brand name: INDOMETHACIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 March 1987
- Application: ANDA071148
- Marketing authorisation holder: ANI PHARMS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 March 1987
- Application: ANDA071149
- Marketing authorisation holder: ANI PHARMS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 1987
- Application: ANDA070674
- Marketing authorisation holder: SANDOZ
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 1987
- Application: ANDA070673
- Marketing authorisation holder: SANDOZ
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 1988
- Application: ANDA071342
- Marketing authorisation holder: TEVA
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 1988
- Application: ANDA071343
- Marketing authorisation holder: TEVA
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 1991
- Application: ANDA072997
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 1991
- Application: ANDA072996
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 August 1992
- Application: ANDA073314
- Marketing authorisation holder: COSETTE
- Local brand name: INDOMETHACIN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 6 February 2002
- Application: ANDA076114
- Marketing authorisation holder: ABLE
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 December 2003
- Application: ANDA076666
- Marketing authorisation holder: ABLE
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 2009
- Application: ANDA079175
- Marketing authorisation holder: AVANTHI INC
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 March 2010
- Application: NDA022536
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: INDOMETHACIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 2010
- Application: ANDA091549
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2010
- Application: ANDA091276
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 April 2011
- Application: ANDA091240
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA201807
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 December 2013
- Application: ANDA202572
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA202139
- Marketing authorisation holder: MYLAN
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 October 2015
- Application: ANDA202706
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 December 2016
- Application: ANDA204243
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 May 2017
- Application: ANDA204853
- Marketing authorisation holder: NOVAST LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 August 2017
- Application: ANDA205215
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 September 2017
- Application: ANDA202711
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 August 2023
- Application: ANDA216184
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: INDOMETHACIN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 12 January 2024
- Application: ANDA217883
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: INDOMETHACIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 February 2025
- Application: ANDA215399
- Marketing authorisation holder: AMNEAL
- Local brand name: INDOMETHACIN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 3 July 2025
- Application: ANDA216905
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: INDOMETHACIN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Application: ANDA070782
- Marketing authorisation holder: HALSEY
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070785
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070487
- Marketing authorisation holder: SUPERPHARM
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070813
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070530
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070529
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA018806
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070353
- Marketing authorisation holder: CYCLE
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA018690
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070635
- Marketing authorisation holder: HALSEY
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070354
- Marketing authorisation holder: CYCLE
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070784
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDOMETHACIN
- Indication: CAPSULE — 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: 22 April 2025 – 22 April 2026
- Total reports: 20
Most-reported reactions
- Alanine Aminotransferase Increased — 2 reports (10%)
- Anaemia — 2 reports (10%)
- Blood Alkaline Phosphatase Increased — 2 reports (10%)
- Gamma-Glutamyltransferase Increased — 2 reports (10%)
- Hyperuricaemia — 2 reports (10%)
- Hypocalcaemia — 2 reports (10%)
- Hypokalaemia — 2 reports (10%)
- Hypomagnesaemia — 2 reports (10%)
- Myelosuppression — 2 reports (10%)
- Neutrophil Count Decreased — 2 reports (10%)
Frequently asked questions
Is Indomethacin suppository approved in United States?
Yes. FDA authorised it on 20 April 1984; FDA authorised it on 4 May 1984; FDA authorised it on 18 May 1984.
Who is the marketing authorisation holder for Indomethacin suppository in United States?
RISING holds the US marketing authorisation.