Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208754

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NDA 208754 describes DOCOSANOL, which is a drug marketed by Alembic, Aurobindo Pharma Ltd, Dr Reddys, Klm Labs Pvt, P And L, P And L Development, and Sun Pharma Canada, and is included in eight NDAs. It is available from forty suppliers. Additional details are available on the DOCOSANOL profile page.

The generic ingredient in DOCOSANOL 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 208754

Tradename:	DOCOSANOL
Applicant:	P And L
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 208754

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	208754	ANDA	Haleon US Holdings LLC	0135-0300	0135-0300-01	1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	208754	ANDA	Haleon US Holdings LLC	0135-0300	0135-0300-02	2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Nov 19, 2018	TE:		RLD:	No

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