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FDA Orange Book · active-ingredient family

Temozolomide

Temozolomide is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TEMODAR · NDA 022277

2

Brand (NDA)

16

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, powder

ProductApplicantApplicationTEApproved
TEMODARRLDMERCK SHARP DOHMENDA 022277—Feb 27, 2009
TEMODARRLD×6MERCK SHARP DOHMENDA 021029—Aug 11, 1999

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
TEMOZOLOMIDE×6HETERO LABS LTD VANDA 210030ABAug 23, 2024
TEMOZOLOMIDE×6NIVAGEN PHARMS INCANDA 213328—Nov 23, 2021
TEMOZOLOMIDE×6APOTEXANDA 204159—Jul 05, 2018
TEMOZOLOMIDE×6ZYDUS PHARMSANDA 206750ABJul 31, 2017
TEMOZOLOMIDE×6DEVA HOLDING ASANDA 207658ABApr 26, 2017
TEMOZOLOMIDE×5WATSON LABS TEVAANDA 203959—Apr 18, 2017
TEMOZOLOMIDE×6ACCORD HLTHCAREANDA 201528ABFeb 27, 2017
TEMOZOLOMIDE×6CHEMI SPAANDA 204639ABNov 23, 2016
TEMOZOLOMIDE×6ANI PHARMSANDA 203490—Jul 13, 2016
TEMOZOLOMIDE×6EXTROVISANDA 205227—Jun 29, 2016
TEMOZOLOMIDE×6RISINGANDA 206309ABApr 27, 2016
TEMOZOLOMIDE×6CHARTWELLANDA 206413ABApr 12, 2016
TEMOZOLOMIDE×6EIRGENANDA 203898—Feb 10, 2016
TEMOZOLOMIDE×6AMNEAL PHARMSANDA 203691ABMay 08, 2015
TEMOZOLOMIDE×6SUN PHARMANDA 201742ABFeb 12, 2014
TEMOZOLOMIDE×6HERITAGEANDA 078879—Mar 01, 2010

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.

Temozolomide — frequently asked questions

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

Agent CTA Background

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