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FDA Orange Book · active-ingredient family

Piroxicam

Piroxicam is approved as 1 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FELDENE · NDA 018147

1

Brand (NDA)

22

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
FELDENERLD×2PFIZERNDA 018147ABApr 06, 1982

Generic (ANDA) products (22)

ProductApplicantApplicationTEApproved
PIROXICAM×2ZYDUS LIFESCIENCESANDA 205585ABJul 17, 2018
PIROXICAM×2BRECKENRIDGEANDA 208991—Feb 21, 2018
PIROXICAM×2STRIDES PHARMAANDA 210347ABJan 26, 2018
PIROXICAM×2MICRO LABSANDA 206152ABDec 29, 2017
PIROXICAM×2HIKMAANDA 209256—Aug 11, 2017
PIROXICAM×2STRIDES PHARMAANDA 206136—Jun 20, 2017
PIROXICAM×2UNICHEMANDA 208340—Apr 13, 2017
PIROXICAM×2FLAMINGO PHARMSANDA 207938—Sep 09, 2016
PIROXICAM×2SUN PHARM INDUSTRIESANDA 073536—Jan 23, 2008
PIROXICAM×2EGISANDA 074808—Jul 08, 1997
PIROXICAM×2IVAX SUB TEVA PHARMSANDA 074148—Jun 03, 1996
PIROXICAM×2WATSON LABSANDA 074287—May 16, 1996
PIROXICAM×2WATSON LABSANDA 074460—Sep 29, 1995
PIROXICAMTEVAANDA 073637—Jan 28, 1994
PIROXICAMTEVAANDA 073638—Jan 28, 1994
PIROXICAM×2SOLIS PHARMSANDA 074118ABJun 15, 1993
PIROXICAM×2CYCLEANDA 073651—Feb 26, 1993
PIROXICAM×2TEVAANDA 074131ABDec 11, 1992
PIROXICAM×2MYLANANDA 074043—Sep 22, 1992
PIROXICAM×2TEVA PHARMSANDA 074103—Aug 28, 1992
PIROXICAM×2PHARMOBEDIENTANDA 074102—Jul 31, 1992
PIROXICAM×2SCSANDA 074036—May 29, 1992

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.

Piroxicam — 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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