Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212385

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NDA 212385 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-two 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-two suppliers are listed for this compound. Additional details are available on the docosanol profile page.

Summary for 212385

Tradename:	DOCOSANOL
Applicant:	P And L Development
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 212385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	212385	ANDA	Walgreens	0363-6510	0363-6510-07	2 g in 1 BOTTLE, PUMP (0363-6510-07)
DOCOSANOL	docosanol	CREAM;TOPICAL	212385	ANDA	Walgreens	0363-6510	0363-6510-14	1 BOTTLE, PUMP in 1 CARTON (0363-6510-14) / 2 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Oct 7, 2022	TE:		RLD:	No

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