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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078163

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NDA 078163 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 078163

Tradename:	TERBINAFINE HYDROCHLORIDE
Applicant:	Orbion Pharms
Ingredient:	terbinafine hydrochloride
Patents:	0

Pharmacology for NDA: 078163

Suppliers and Packaging for NDA: 078163

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078163	ANDA	A-S Medication Solutions	50090-7300	50090-7300-0	30 TABLET in 1 BOTTLE (50090-7300-0)
TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078163	ANDA	A-S Medication Solutions	50090-7300	50090-7300-1	90 TABLET in 1 BOTTLE (50090-7300-1)

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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