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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214454

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NDA 214454 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 214454

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

Suppliers and Packaging for NDA: 214454

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	214454	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-1406	51672-1406-2	2 TUBE in 1 PACKAGE (51672-1406-2) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	214454	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-1406	51672-1406-3	1 TUBE in 1 PACKAGE (51672-1406-3) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Oct 26, 2023	TE:		RLD:	No

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