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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078199

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NDA 078199 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Canada, Anda Repository, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, Orbion Pharms, Roxane, and Wockhardt, and is included in sixteen NDAs. It is available from thirty-eight suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.

The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.

Summary for 078199

Tradename:	TERBINAFINE HYDROCHLORIDE
Applicant:	Chartwell
Ingredient:	terbinafine hydrochloride
Patents:	0

Pharmacology for NDA: 078199

Suppliers and Packaging for NDA: 078199

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078199	ANDA	Chartwell RX, LLC	62135-572	62135-572-30	30 TABLET in 1 BOTTLE (62135-572-30)
TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078199	ANDA	Chartwell RX, LLC	62135-572	62135-572-90	90 TABLET in 1 BOTTLE (62135-572-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Jul 2, 2007	TE:	AB	RLD:	No

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