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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Cantor Fitzgerald

Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040027

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NDA 040027 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-three 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.
Pharmacology for NDA: 040027
Suppliers and Packaging for NDA: 040027

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Jul 31, 1996TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Fish and Richardson
US Army

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