FDA — authorised 12 September 1945
- Application: NDA005794
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: SULTRIN
- Indication: TABLET — VAGINAL
- Status: approved
🇺🇸 TRIPLE SULFA in United States
FDA authorised TRIPLE SULFA on 12 September 1945
Marketing authorisations
FDA — authorised 2 June 1976
- Application: ANDA080280
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: TRIPLE SULFA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 July 1982
- Application: ANDA087887
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: TRYSUL
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 15 November 1982
- Application: ANDA087285
- Marketing authorisation holder: PADAGIS US
- Local brand name: TRIPLE SULFA
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 9 June 1986
- Application: ANDA088607
- Marketing authorisation holder: COSETTE
- Local brand name: GYNE-SULF
- Indication: CREAM — VAGINAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA087864
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: TRIPLE SULFA
- Indication: CREAM — VAGINAL
- Status: approved
FDA
- Application: ANDA088462
- Marketing authorisation holder: PHARMADERM
- Local brand name: TRIPLE SULFA
- Indication: TABLET — VAGINAL
- Status: approved
FDA
- Application: ANDA088463
- Marketing authorisation holder: FOUGERA
- Local brand name: TRIPLE SULFA
- Indication: TABLET — VAGINAL
- Status: approved
FDA
- Application: ANDA080086
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: TRIPLE SULFA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086424
- Marketing authorisation holder: FOUGERA
- Local brand name: TRIPLE SULFA
- Indication: CREAM — VAGINAL
- Status: approved
TRIPLE SULFA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is TRIPLE SULFA approved in United States?
Yes. FDA authorised it on 12 September 1945; FDA authorised it on 2 June 1976; FDA authorised it on 23 July 1982.
Who is the marketing authorisation holder for TRIPLE SULFA in United States?
ORTHO MCNEIL PHARM holds the US marketing authorisation.