Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020941

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NDA 020941 describes ABREVA, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the ABREVA profile page.

The generic ingredient in ABREVA is docosanol. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the docosanol profile page.

Summary for 020941

Tradename:	ABREVA
Applicant:	Haleon Us Holdings
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 020941

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABREVA	docosanol	CREAM;TOPICAL	020941	NDA	Haleon US Holdings LLC	0135-0200	0135-0200-01	2 g in 1 TUBE (0135-0200-01)
ABREVA	docosanol	CREAM;TOPICAL	020941	NDA	Haleon US Holdings LLC	0135-0200	0135-0200-03	2 g in 1 BOTTLE, PUMP (0135-0200-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Jul 25, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 020941

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000	4,874,794	⤷ Start Trial
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000	5,534,554	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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