FDA — authorised 25 August 1965
- Application: NDA012715
- Marketing authorisation holder: ROCHE
- Local brand name: GANTANOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Azo Gantanol in United States
FDA authorised Azo Gantanol on 25 August 1965
Marketing authorisations
FDA — authorised 30 July 1973
- Application: NDA017376
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: SEPTRA DS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1975
- Application: NDA017560
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: BACTRIM PEDIATRIC
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 May 1975
- Application: NDA017598
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: SEPTRA GRAPE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 May 1981
- Application: NDA018242
- Marketing authorisation holder: TEVA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1982
- Application: NDA018598
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 1983
- Application: NDA018615
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: SULFATRIM PEDIATRIC
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 January 1983
- Application: NDA018812
- Marketing authorisation holder: TEVA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 May 1983
- Application: NDA018854
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 1983
- Application: NDA018852
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 1983
- Application: ANDA087189
- Marketing authorisation holder: BARR
- Local brand name: SULFAMETHOXAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 1984
- Application: ANDA070002
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 November 1984
- Application: ANDA070000
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 1984
- Application: ANDA070007
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 1984
- Application: ANDA070006
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1985
- Application: ANDA070032
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: SULFAMETHOPRIM-DS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1985
- Application: ANDA070022
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: SULFAMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 1985
- Application: ANDA070048
- Marketing authorisation holder: TEVA
- Local brand name: COTRIM D.S.
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 1985
- Application: ANDA070034
- Marketing authorisation holder: TEVA
- Local brand name: COTRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 1985
- Application: ANDA070065
- Marketing authorisation holder: SUPERPHARM
- Local brand name: SULFATRIM-SS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 1985
- Application: ANDA070066
- Marketing authorisation holder: SUPERPHARM
- Local brand name: SULFATRIM-DS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 1985
- Application: ANDA070215
- Marketing authorisation holder: PLIVA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 1985
- Application: ANDA070216
- Marketing authorisation holder: PLIVA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1985
- Application: ANDA070037
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1985
- Application: ANDA070030
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 1985
- Application: ANDA070028
- Marketing authorisation holder: ANI PHARMS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 August 1986
- Application: ANDA071017
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 1987
- Application: ANDA070627
- Marketing authorisation holder: HIKMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1987
- Application: ANDA070628
- Marketing authorisation holder: HIKMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 May 1988
- Application: ANDA072399
- Marketing authorisation holder: NASKA
- Local brand name: TRIMETH/SULFA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 August 1991
- Application: ANDA072768
- Marketing authorisation holder: ROXANE
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1991
- Application: ANDA073303
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 1997
- Application: ANDA074650
- Marketing authorisation holder: HIKMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 January 2005
- Application: ANDA076899
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 October 2005
- Application: ANDA076817
- Marketing authorisation holder: VISTA PHARMS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 2007
- Application: ANDA077785
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 January 2007
- Application: ANDA078060
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 2010
- Application: ANDA090624
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 2010
- Application: ANDA091348
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 December 2010
- Application: ANDA090828
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2019
- Application: ANDA212231
- Marketing authorisation holder: SOMERSET
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Azo Gantanol for labeling indications on 2025-02-21. The marketing authorisation holder is SOMERSET. Azo Gantanol was approved under the standard expedited pathway.
FDA — authorised 5 January 2021
- Application: ANDA212699
- Marketing authorisation holder: LUPIN
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 February 2022
- Application: ANDA214330
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA087662
- Marketing authorisation holder: ASCOT
- Local brand name: SULFAMETHOXAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071816
- Marketing authorisation holder: SHIONOGI
- Local brand name: UROPLUS DS
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070063
- Marketing authorisation holder: USL PHARMA
- Local brand name: SULMEPRIM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA072383
- Marketing authorisation holder: BEDFORD
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070204
- Marketing authorisation holder: USL PHARMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070223
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071341
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: SULFAMETHOPRIM
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA072398
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: TRIMETH/SULFA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA070203
- Marketing authorisation holder: USL PHARMA
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071300
- Marketing authorisation holder: INTERPHARM
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087307
- Marketing authorisation holder: SHIONOGI
- Local brand name: UROBAK
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071299
- Marketing authorisation holder: INTERPHARM
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072289
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: TRIMETH/SULFA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA085053
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA018946
- Marketing authorisation holder: HEATHER
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086163
- Marketing authorisation holder: HEATHER
- Local brand name: SULFAMETHOXAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086000
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070064
- Marketing authorisation holder: USL PHARMA
- Local brand name: SULMEPRIM PEDIATRIC
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA072769
- Marketing authorisation holder: ROXANE
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071556
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071815
- Marketing authorisation holder: SHIONOGI
- Local brand name: UROPLUS SS
- Indication: TABLET — ORAL
- Status: approved
Azo Gantanol 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 Azo Gantanol approved in United States?
Yes. FDA authorised it on 25 August 1965; FDA authorised it on 30 July 1973; FDA authorised it on 15 April 1975.
Who is the marketing authorisation holder for Azo Gantanol in United States?
ROCHE holds the US marketing authorisation.