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FDA Orange Book · active-ingredient family

Orphenadrine citrate

Orphenadrine citrate is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NORFLEX · NDA 013055

2

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet, extended release

ProductApplicantApplicationTEApproved
NORFLEXRLDPAI HOLDINGS PHARMNDA 013055—Approved Prior to Jan 1, 1982
NORFLEXRLDBAUSCHNDA 012157—Approved Prior to Jan 1, 1982

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
ORPHENADRINE CITRATEUNICHEMANDA 091158ABJul 27, 2012
ORPHENADRINE CITRATESAGENT PHARMSANDA 090585APAug 30, 2011
ORPHENADRINE CITRATERISINGANDA 040484APMay 24, 2006
ORPHENADRINE CITRATEHIKMAANDA 040463APMar 04, 2003
ORPHENADRINE CITRATESTEVENS JANDA 040368—Jun 23, 2000
ORPHENADRINE CITRATESANDOZANDA 040327ABFeb 15, 2000
ORPHENADRINE CITRATERISINGANDA 040249ABJan 29, 1999
ORPHENADRINE CITRATELUPINANDA 040284ABJun 19, 1998
ORPHENADRINE CITRATEASCOTANDA 088067—Apr 06, 1983
ORPHENADRINE CITRATEWATSON LABSANDA 084779APMar 15, 1982
ORPHENADRINE CITRATEWATSON LABSANDA 087062—Approved Prior to Jan 1, 1982
ORPHENADRINE CITRATESANDOZANDA 085046—Approved Prior to Jan 1, 1982
ORPHENADRINE CITRATEWATSON LABSANDA 084303—Approved Prior to Jan 1, 1982

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.

Orphenadrine citrate — 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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