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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 215839

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NDA 215839 describes DOCOSANOL, which is a drug marketed by Alembic, Aurobindo Pharma Ltd, P And L, P And L Development, and Taro, and is included in five NDAs. It is available from thirty-nine suppliers. Additional details are available on the DOCOSANOL profile page.

The generic ingredient in DOCOSANOL is docosanol. There are five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the docosanol profile page.

Summary for 215839

Tradename:	DOCOSANOL
Applicant:	Alembic
Ingredient:	docosanol
Patents:	0

Suppliers and Packaging for NDA: 215839

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	215839	ANDA	Rugby Laboratories	0536-1427	0536-1427-04	1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	215839	ANDA	Cosette Pharmaceuticals, Inc.	0713-0353	0713-0353-02	1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	May 3, 2022	TE:		RLD:	No

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