Assyro AI

FDA Orange Book · active-ingredient family

Sulfamethoxazole; trimethoprim

Sulfamethoxazole; trimethoprim is approved as 13 brand and 52 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BACTRIM · NDA 018374

13

Brand (NDA)

52

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, suspension, tablet

ProductApplicantApplicationTEApproved
BACTRIMRLDSUN PHARM INDS INCNDA 018374—Approved Prior to Jan 1, 1982
BACTRIMRLD×2SUN PHARM INDUSTRIESNDA 017560—Approved Prior to Jan 1, 1982
BACTRIMRLD×2SUN PHARM INDUSTRIESNDA 017377ABApproved Prior to Jan 1, 1982
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2HEATHERNDA 018946—Aug 10, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIMWATSON LABSNDA 018852—May 09, 1983
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHWATSON LABSNDA 018854—May 09, 1983
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2TEVANDA 018812—Jan 28, 1983
SULFATRIM×2PHARM ASSOCNDA 018615—Jan 07, 1983
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2FOSUN PHARMANDA 018598—May 19, 1982
SEPTRAMONARCH PHARMSNDA 018452—Approved Prior to Jan 1, 1982
SEPTRA×2MONARCH PHARMSNDA 017598—Approved Prior to Jan 1, 1982
SEPTRA×2MONARCH PHARMSNDA 017376—Approved Prior to Jan 1, 1982
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2TEVANDA 018242—Approved Prior to Jan 1, 1982

Generic (ANDA) products (52)

ProductApplicantApplicationTEApproved
SULFAMETHOXAZOLE AND TRIMETHOPRIMNOVITIUM PHARMAANDA 214330ABFeb 08, 2022
SULFAMETHOXAZOLE AND TRIMETHOPRIMLUPINANDA 212699—Jan 05, 2021
SULFAMETHOXAZOLE AND TRIMETHOPRIMSOMERSETANDA 212231APJun 26, 2019
SULFAMETHOXAZOLE AND TRIMETHOPRIMPHARMOBEDIENTANDA 206607APAug 30, 2017
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2GLENMARK PHARMS LTDANDA 090828ABDec 22, 2010
SULFAMETHOXAZOLE AND TRIMETHOPRIMAUROBINDO PHARMAANDA 091348ABJun 08, 2010
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2AUROBINDO PHARMAANDA 090624ABFeb 16, 2010
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2CHARTWELL MOLECULESANDA 078060ABJan 25, 2007
SULFAMETHOXAZOLE AND TRIMETHOPRIMCHARTWELL MOLECULARANDA 077785ABJan 24, 2007
SULFAMETHOXAZOLE AND TRIMETHOPRIMPRASCOANDA 077612ABNov 13, 2006
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2VISTA PHARMSANDA 076817ABOct 07, 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2AMNEAL PHARMS NYANDA 076899ABJan 27, 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIMHIKMAANDA 074650—Dec 29, 1997
SULFAMETHOXAZOLE AND TRIMETHOPRIMHOSPIRAANDA 073199—Sep 11, 1992
SULFAMETHOXAZOLE AND TRIMETHOPRIMBEDFORDANDA 072383—Apr 29, 1992
SULFAMETHOXAZOLE AND TRIMETHOPRIMTEVA PHARMS USAANDA 073303APOct 31, 1991
SULFAMETHOXAZOLE AND TRIMETHOPRIMROXANEANDA 072768—Aug 30, 1991
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHROXANEANDA 072769—Aug 30, 1991
SULFAMETHOXAZOLE AND TRIMETHOPRIMMARTEC USA LLCANDA 072408—Dec 07, 1988
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHMARTEC USA LLCANDA 072417—Dec 07, 1988
TRIMETH/SULFAALPHARMA US PHARMSANDA 072289—May 23, 1988
TRIMETH/SULFAALPHARMA US PHARMSANDA 072398—May 23, 1988
TRIMETH/SULFANASKAANDA 072399—May 23, 1988
SULFAMETHOXAZOLE AND TRIMETHOPRIMABRAXIS PHARMANDA 070223—Dec 29, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIMHIKMAANDA 070627—Dec 29, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIMHIKMAANDA 070628—Dec 29, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIMWATSON LABSANDA 071556—Dec 29, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIMINTERPHARMANDA 071299—Oct 27, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIMINTERPHARMANDA 071300—Oct 27, 1987
UROPLUS DSSHIONOGIANDA 071816—Sep 28, 1987
UROPLUS SSSHIONOGIANDA 071815—Sep 28, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIMANI PHARMSANDA 070028—Jun 02, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHHERITAGE PHARMA AVETANDA 070037—Jun 02, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTHHERITAGE PHARMA AVETANDA 070030—Jun 02, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2AIPING PHARM INCANDA 070890—Nov 13, 1986
SULFAMETHOXAZOLE AND TRIMETHOPRIM×2SUN PHARM INDUSTRIESANDA 071017ABAug 25, 1986
SULMEPRIMUSL PHARMAANDA 070063—Aug 01, 1986
SULMEPRIM PEDIATRICUSL PHARMAANDA 070064—Aug 01, 1986
SULFAMETHOXAZOLE AND TRIMETHOPRIMUSL PHARMAANDA 070203—Nov 08, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIMUSL PHARMAANDA 070204—Nov 08, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIMPLIVAANDA 070215—Sep 10, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIMPLIVAANDA 070216—Sep 10, 1985
SULFATRIM-DSSUPERPHARMANDA 070066—Jun 24, 1985
SULFATRIM-SSSUPERPHARMANDA 070065—Jun 24, 1985
COTRIMTEVAANDA 070034—May 16, 1985
COTRIM D.S.TEVAANDA 070048—Mar 18, 1985
SULFAMETHOPRIMNOVEL LABS INCANDA 070022—Feb 15, 1985
SULFAMETHOPRIM-DSNOVEL LABS INCANDA 070032—Feb 15, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIMMUTUAL PHARMANDA 070006—Nov 14, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHMUTUAL PHARMANDA 070007—Nov 14, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIMWATSON LABSANDA 070002—Nov 07, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIMWATSON LABSANDA 070000—Nov 07, 1984

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Sulfamethoxazole; trimethoprim — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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