Last Updated: September 24, 2026

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, 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 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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