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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

Tradenames:3
Patents:1
Applicants:16
NDAs:24
Drug Master File Entries: see list23
Suppliers: see list1

Tentative approvals for TERBINAFINE

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

Clinical Trials for: terbinafine

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
Status: Completed Condition: Onychomycosis/Onycholysis and Tinea Pedis

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Status: Completed Condition: Tinea Capitis

Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
Status: Completed Condition: Onychomycosis

Terbinafine HCl 250 mg Tablet Under Fasting Conditions
Status: Completed Condition: Healthy

Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Generics
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL078157Jul 2, 2007RXNo<disabled><disabled>
Novartis
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020980Mar 9, 1999OTCYes<disabled><disabled>
Novartis
LAMISIL
terbinafine hydrochloride
SOLUTION;TOPICAL020749Oct 17, 1997DISCNNo<disabled><disabled>
Taro
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
CREAM;TOPICAL077511Jul 2, 2007OTCNo<disabled><disabled>
Mylan
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077136Jul 2, 2007DISCNNo<disabled><disabled>
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