Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214454

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NDA 214454 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 214454

Tradename:	DOCOSANOL
Applicant:	Sun Pharma Canada
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 214454

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	214454	ANDA	Publix Super Markets Inc.	41415-660	41415-660-03	1 TUBE in 1 PACKAGE (41415-660-03) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	214454	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1406	51672-1406-2	2 TUBE in 1 PACKAGE (51672-1406-2) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Oct 26, 2023	TE:		RLD:	No

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