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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011265

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NDA 011265 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Hi Tech Pharma, and Tris Pharma Inc, and is included in four NDAs. It is available from two suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 011265

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 2, 1984TE:RLD:Yes

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