Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212385

✉ Email this page to a colleague

« Back to Dashboard

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 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.