FDA — authorised 28 September 1984
- Application: NDA018832
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Aloprim in United States
FDA authorised Aloprim on 28 September 1984
Marketing authorisations
FDA — authorised 28 September 1984
- Application: NDA018877
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1985
- Application: ANDA070147
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1985
- Application: ANDA070150
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 December 1985
- Application: ANDA070467
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 December 1985
- Application: ANDA070466
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 1986
- Application: ANDA018659
- Marketing authorisation holder: MYLAN
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 1987
- Application: ANDA071450
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA071586
- Marketing authorisation holder: DR REDDYS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA071587
- Marketing authorisation holder: DR REDDYS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 May 1996
- Application: NDA020298
- Marketing authorisation holder: MYLAN
- Local brand name: ALOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2003
- Application: ANDA075798
- Marketing authorisation holder: PH HEALTH
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2005
- Application: ANDA077353
- Marketing authorisation holder: CHARTWELL
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 2007
- Application: ANDA078390
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 2007
- Application: ANDA078253
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 March 2011
- Application: ANDA090637
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 2013
- Application: ANDA203154
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2016
- Application: ANDA204467
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2017
- Application: NDA209203
- Marketing authorisation holder: IRONWOOD PHARMS INC
- Local brand name: DUZALLO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 October 2017
- Application: ANDA210117
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2019
- Application: ANDA211820
- Marketing authorisation holder: UNICHEM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 2022
- Application: ANDA214443
- Marketing authorisation holder: HARMAN FINOCHEM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 2023
- Application: ANDA217748
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2023
- Application: ANDA211807
- Marketing authorisation holder: LUPIN
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 2025
- Application: ANDA215091
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 March 2026
- Application: ANDA076870
- Marketing authorisation holder: HIKMA
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Aloprim, manufactured by HIKMA, on 13 March 2026. This approval was granted under the standard expedited pathway for the manufacturing (CMC) indication. The application number for this approval is ANDA076870.
FDA
- Application: ANDA070951
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA018241
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070950
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ALLOPURINOL
- Indication: TABLET — ORAL
- Status: approved
Aloprim in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Aloprim approved in United States?
Yes. FDA authorised it on 28 September 1984; FDA authorised it on 28 September 1984; FDA authorised it on 10 December 1985.
Who is the marketing authorisation holder for Aloprim in United States?
WATSON LABS holds the US marketing authorisation.