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FDA Orange Book · active-ingredient family

Valproic acid

Valproic acid is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:STAVZOR · NDA 022152

3

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, capsule, delayed release, syrup

ProductApplicantApplicationTEApproved
STAVZORRLD×3BIONPHARMANDA 022152—Jul 29, 2008
DEPAKENERLDABBVIENDA 018081—Approved Prior to Jan 1, 1982
DEPAKENERLDABBVIENDA 018082—Approved Prior to Jan 1, 1982

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
VALPROIC ACIDHIBROW HLTHCAREANDA 207611—Aug 05, 2019
VALPROIC ACIDSUN PHARM INDS LTDANDA 091037—Feb 22, 2013
VALPROIC ACIDQUAGENANDA 090517AAMay 28, 2010
VALPROIC ACIDLANNETT CO INCANDA 077960—Oct 13, 2006
VALPROIC ACIDPAI HOLDINGSANDA 077105—Jul 29, 2005
VALPROIC ACIDCHARTWELL RXANDA 075782AADec 22, 2000
VALPROIC ACIDPHARM ASSOCANDA 075379AADec 15, 2000
VALPROIC ACIDHIKMAANDA 074060—Jan 13, 1995
VALPROIC ACIDBIONPHARMAANDA 073484ABJun 29, 1993
VALPROIC ACIDANI PHARMSANDA 073178AAAug 25, 1992
VALPROIC ACIDCATALENTANDA 073229ABOct 29, 1991
VALPROIC ACIDSCHERER RPANDA 070195—Jul 02, 1987
VALPROIC ACIDCHARTWELL RXANDA 070631—Jun 11, 1987
VALPROIC ACIDPHARMOBEDIENT CNSLTGANDA 070868—Jul 01, 1986
VALPROIC ACIDPAR PHARMANDA 070431—Feb 28, 1986

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.

Valproic acid — 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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