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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 208754

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NDA 208754 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 208754

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

Suppliers and Packaging for NDA: 208754

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCOSANOL	docosanol	CREAM;TOPICAL	208754	ANDA	Haleon US Holdings LLC	0135-0300	0135-0300-01	1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE
DOCOSANOL	docosanol	CREAM;TOPICAL	208754	ANDA	Haleon US Holdings LLC	0135-0300	0135-0300-02	2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL			Strength	10%
Approval Date:	Nov 19, 2018	TE:		RLD:	No

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