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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
Formulation / Manufacturing:see details

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

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

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

Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
Status: Recruiting Condition: Onychomycosis

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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