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Details for Generic Name: terbinafine

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

Drug Master File Entries: see list23
Suppliers: 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
Cipla Ltd
terbinafine hydrochloride
TABLET;ORAL077137-001Jul 2, 2007RXNo<disabled><disabled>
terbinafine hydrochloride
SOLUTION;TOPICAL020749-001Oct 17, 1997DISCNNo<disabled><disabled>
Dr Reddys Labs Inc
terbinafine hydrochloride
TABLET;ORAL076390-001Jul 2, 2007RXNo<disabled><disabled>
Invagen Pharms
terbinafine hydrochloride
TABLET;ORAL077533-001Jul 2, 2007RXNo<disabled><disabled>
Gedeon Richter Usa
terbinafine hydrochloride
TABLET;ORAL077065-001Jul 2, 2007DISCNNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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