FDA — authorised 30 July 1973
- Marketing authorisation holder: MUTUAL PHARM
- Status: approved
🇺🇸 Trimethoprim in United States
FDA authorised Trimethoprim on 30 July 1973
Marketing authorisations
FDA — authorised 30 May 1980
- Application: NDA017952
- Marketing authorisation holder: ROCHE
- Local brand name: TRIMPEX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 1980
- Application: NDA017943
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: PROLOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 July 1982
- Application: NDA018679
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 1985
- Application: ANDA070049
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1986
- Application: ANDA070494
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1986
- Application: NDA018615
- Marketing authorisation holder: PHARM ASSOC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 March 1986
- Application: ANDA070495
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 1987
- Application: ANDA071259
- Marketing authorisation holder: TEVA
- Local brand name: TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 September 2008
- Application: ANDA077785
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
FDA — authorised 15 June 2011
- Application: ANDA091437
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 October 2014
- Application: ANDA078060
- Marketing authorisation holder: CHARTWELL MOLECULES
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 September 2022
- Application: ANDA076899
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
FDA — authorised 21 February 2025
- Application: ANDA212231
- Marketing authorisation holder: SOMERSET
- Indication: Labeling
- Status: approved
The FDA approved Trimethoprim for labeling by SOMERSET on February 21, 2025. This approval was granted under the standard expedited pathway. The application number for this approval is ANDA212231.
Trimethoprim in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Trimethoprim approved in United States?
Yes. FDA authorised it on 30 July 1973; FDA authorised it on 30 May 1980; FDA authorised it on 30 May 1980.
Who is the marketing authorisation holder for Trimethoprim in United States?
MUTUAL PHARM holds the US marketing authorisation.