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FDA Orange Book · active-ingredient family

Nystatin; triamcinolone acetonide

Nystatin; triamcinolone acetonide is approved in 42 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

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Brand (NDA)

42

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (42)

ProductApplicantApplicationTEApproved
NYSTATIN AND TRIAMCINOLONE ACETONIDEMACLEODS PHARMS LTDANDA 214181ATJul 13, 2022
NYSTATIN AND TRIAMCINOLONE ACETONIDEALEMBICANDA 214186ATMar 04, 2022
NYSTATIN AND TRIAMCINOLONE ACETONIDEMACLEODS PHARMS LTDANDA 214751ATAug 17, 2021
NYSTATIN AND TRIAMCINOLONE ACETONIDEALEMBICANDA 214090ATMar 31, 2021
NYSTATIN AND TRIAMCINOLONE ACETONIDETORRENTANDA 213142—Jul 14, 2020
NYSTATIN AND TRIAMCINOLONE ACETONIDECHARTWELL RXANDA 207316—Nov 18, 2019
NYSTATIN AND TRIAMCINOLONE ACETONIDEZYDUS LIFESCIENCESANDA 207764ATNov 08, 2018
NYSTATIN AND TRIAMCINOLONE ACETONIDELUPINANDA 208205ATMay 31, 2018
NYSTATIN AND TRIAMCINOLONE ACETONIDEAMNEALANDA 209990ATFeb 15, 2018
NYSTATIN AND TRIAMCINOLONE ACETONIDESTRIDES PHARMAANDA 210077—Jan 29, 2018
NYSTATIN AND TRIAMCINOLONE ACETONIDECROWN LABS INCANDA 207730ATDec 26, 2017
NYSTATIN AND TRIAMCINOLONE ACETONIDECROWN LABS INCANDA 207731—Dec 26, 2017
NYSTATIN AND TRIAMCINOLONE ACETONIDEPADAGIS ISRAELANDA 208479ATAug 14, 2017
NYSTATIN AND TRIAMCINOLONE ACETONIDEEPIC PHARMA LLCANDA 207217ATAug 04, 2017
NYSTATIN AND TRIAMCINOLONE ACETONIDEDR REDDYSANDA 207741ATJan 31, 2017
NYSTATIN AND TRIAMCINOLONE ACETONIDEPAI HOLDINGS PHARMANDA 208287—Dec 30, 2016
NYSTATIN AND TRIAMCINOLONE ACETONIDERISINGANDA 206785ATDec 29, 2016
NYSTATIN AND TRIAMCINOLONE ACETONIDEPADAGIS ISRAELANDA 207380ATDec 20, 2016
NYSTATIN AND TRIAMCINOLONE ACETONIDECHARTWELL RXANDA 208326ATOct 26, 2016
NYSTATIN AND TRIAMCINOLONE ACETONIDEGLENMARK PHARMS LTDANDA 208136—Oct 24, 2016
NYSTATIN AND TRIAMCINOLONE ACETONIDEGLENMARK PHARMS LTDANDA 208300—Jun 23, 2016
NYSTATIN AND TRIAMCINOLONE ACETONIDESUN PHARMA CANADAANDA 063305ATMar 29, 1993
NYSTATIN AND TRIAMCINOLONE ACETONIDEALPHARMA US PHARMSANDA 063010—Dec 20, 1988
NYSTATIN AND TRIAMCINOLONE ACETONIDESUN PHARMA CANADAANDA 062364ATDec 22, 1987
NYSTATIN AND TRIAMCINOLONE ACETONIDESUN PHARMA CANADAANDA 062347—Mar 30, 1987
MYKACETCOSETTEANDA 062733—Mar 06, 1987
NYSTATIN AND TRIAMCINOLONE ACETONIDEPHARMAFAIRANDA 062657—Jul 30, 1986
NYSTATIN AND TRIAMCINOLONE ACETONIDEPHARMAFAIRANDA 062656—Jul 30, 1986
MYCO-TRIACET IITEVAANDA 062045—Nov 26, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDEPERRIGO NEW YORKANDA 062280—Oct 10, 1985
MYTREX FSAVAGE LABSANDA 062601—Oct 09, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDEFOUGERA PHARMS INCANDA 062602ATOct 09, 1985
NYSTATIN-TRIAMCINOLONE ACETONIDEPHARMADERMANDA 062603—Oct 09, 1985
MYTREX FSAVAGE LABSANDA 062597—Oct 08, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDEFOUGERA PHARMS INCANDA 062599ATOct 08, 1985
NYSTATIN TRIAMCINOLONE ACETONIDEPHARMADERMANDA 062596—Oct 08, 1985
MYCO-TRIACET IITEVAANDA 061954—Sep 20, 1985
MYCOLOG-IIMYLANANDA 060572—Jun 28, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDEPERRIGO NEW YORKANDA 062186—Jun 06, 1985
MYKACETCOSETTEANDA 062367—May 28, 1985
MYCOLOG-IIMYLANANDA 062606—May 15, 1985
MYCOLOG-IIDELCOR ASSET CORPANDA 060576—May 01, 1985

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.

Nystatin; triamcinolone acetonide — frequently asked questions

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

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