FDA — authorised 30 July 1973
- Application: NDA017376
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: SEPTRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Septra in United States
FDA authorised Septra on 30 July 1973
Marketing authorisations
FDA — authorised 30 July 1973
- Application: NDA017377
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: BACTRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1975
- Application: NDA017560
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: BACTRIM
- Indication: SUSPENSION — ORAL
- Status: approved
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: NDA018374
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: BACTRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Septra approved in United States?
Yes. FDA authorised it on 30 July 1973; FDA authorised it on 30 July 1973; FDA authorised it on 15 April 1975.
Who is the marketing authorisation holder for Septra in United States?
MONARCH PHARMS holds the US marketing authorisation.