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Generated: May 27, 2017

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Terbinafine hydrochloride - Generic Drug Details

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What are the generic drug sources for terbinafine hydrochloride and what is the scope of terbinafine hydrochloride freedom to operate?

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

There are twenty-five drug master file entries for terbinafine hydrochloride. Fifty-four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: terbinafine hydrochloride

Drug Master File Entries: see list25
Suppliers / Packagers: see list54
Bulk Api Vendors: see list66
Clinical Trials: see list998
Patent Applications: see list1,184
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:terbinafine hydrochloride at DailyMed

Pharmacology for Ingredient: terbinafine hydrochloride

Drug ClassAllylamine Antifungal


Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 250MG BASETABLET; ORAL
► Subscribe► SubscribeEQ 250MG BASETABLET;ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma
terbinafine hydrochloride
TABLET;ORAL078297-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe
terbinafine hydrochloride
TABLET;ORAL078199-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Inc
terbinafine hydrochloride
TABLET;ORAL076390-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe
terbinafine hydrochloride
GRANULE;ORAL022071-001Sep 28, 2007RXYesNo► Subscribe► Subscribe
Harris Pharm
terbinafine hydrochloride
TABLET;ORAL077919-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe
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