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Terbinafine - Generic Drug Details

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Terbinafine is the generic ingredient in three branded drugs marketed by Glaxosmithkline Cons, Novartis, Taro, Breckenridge Pharm, Harris Pharm, Roxane, Wockhardt, Invagen Pharms, Mylan, Cipla Ltd, Glenmark Generics, Orchid Hlthcare, Gedeon Richter Usa, Teva, Dr Reddys Labs Inc, Aurobindo Pharma, and Apotex, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for terbinafine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: terbinafine

Tradenames:3
Patents:0
Applicants:17
NDAs:24
Drug Master File Entries: see list23
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Tentative approvals for TERBINAFINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 250MG BASE

Clinical Trials for: terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
LAMISIL
terbinafine hydrochloride
GRANULE;ORAL022071-001Sep 28, 2007RXNo<disabled><disabled>
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 2006OTCYes<disabled><disabled>
Glenmark Generics
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL078157-001Jul 2, 2007RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: terbinafine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19986,005,001*PED<disabled>
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19986,121,314*PED<disabled>
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19984,680,291<disabled>
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