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Last Updated: November 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:OTCDosage:CREAM;TOPICALStrength10%
Approval Date:May 3, 2022TE:RLD:No

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