FDA — authorised 30 July 1973
- Application: NDA017376
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: SEPTRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Trimethoprim and sulfamethoxazole in United States
FDA authorised Trimethoprim and sulfamethoxazole on 30 July 1973
Marketing authorisations
FDA — authorised 31 May 1975
- Application: NDA017598
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: SEPTRA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 June 1981
- Application: NDA018452
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: SEPTRA
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is Trimethoprim and sulfamethoxazole approved in United States?
Yes. FDA authorised it on 30 July 1973; FDA authorised it on 31 May 1975; FDA authorised it on 23 June 1981.
Who is the marketing authorisation holder for Trimethoprim and sulfamethoxazole in United States?
MONARCH PHARMS holds the US marketing authorisation.