Last Updated: September 28, 2026

Details for New Drug Application (NDA): 214613

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NDA 214613 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-one 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-one suppliers are listed for this compound. Additional details are available on the docosanol profile page.

Summary for 214613

Tradename:	DOCOSANOL
Applicant:	Dr Reddys
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 214613

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	214613	ANDA	Dr.Reddys' Laboratories Inc	43598-044	43598-044-02	1 TUBE in 1 CARTON (43598-044-02) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	214613	ANDA	Dr.Reddys' Laboratories Inc	43598-044	43598-044-33	3 TUBE in 1 CARTON (43598-044-33) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Oct 3, 2025	TE:		RLD:	No

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