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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217090

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NDA 217090 describes DOCOSANOL, which is a drug marketed by Alembic, Aurobindo Pharma Ltd, Dr Reddys, P And L, P And L Development, and Sun Pharma Canada, and is included in seven NDAs. It is available from forty-one suppliers. Additional details are available on the DOCOSANOL profile page.

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

Summary for 217090

Tradename:	DOCOSANOL
Applicant:	Aurobindo Pharma Ltd
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 217090

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	217090	ANDA	Blistex Inc.	10157-2124	10157-2124-2	1 TUBE in 1 BLISTER PACK (10157-2124-2) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	217090	ANDA	KROGER COMPANY	30142-286	30142-286-02	1 TUBE in 1 PACKAGE (30142-286-02) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Mar 1, 2024	TE:		RLD:	No

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