Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220017

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NDA 220017 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 220017

Tradename:	DOCOSANOL
Applicant:	Klm Labs Pvt
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 220017

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	220017	ANDA	KLM Laboratories Private Limited	84725-001	84725-001-01	1 TUBE in 1 PACKAGE (84725-001-01) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	220017	ANDA	KLM Laboratories Private Limited	84725-001	84725-001-02	1 BOTTLE, PUMP in 1 PACKAGE (84725-001-02) / 2 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Jul 31, 2026	TE:		RLD:	No

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