Details for New Drug Application (NDA): 020980

✉ Email this page to a colleague

NDA 020980 describes LAMISIL, which is a drug marketed by Karo Hlthcare and Novartis and is included in eight NDAs. It is available from four suppliers. Additional details are available on the LAMISIL profile page.

The generic ingredient in LAMISIL is terbinafine. There are twenty-seven drug master file entries for this compound. Additional details are available on the terbinafine profile page.

Summary for 020980

Tradename:	LAMISIL
Applicant:	Karo Hlthcare
Ingredient:	terbinafine hydrochloride
Patents:	0

Pharmacology for NDA: 020980

Suppliers and Packaging for NDA: 020980

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980	NDA	Haleon US Holdings LLC	0067-3998	0067-3998-30	1 TUBE in 1 CARTON (0067-3998-30) / 30 g in 1 TUBE
LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980	NDA	Haleon US Holdings LLC	0067-3998	0067-3998-42	1 TUBE in 1 CARTON (0067-3998-42) / 12 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Mar 9, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020980

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999	4,680,291	⤷ Subscribe
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999	4,755,534*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.