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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Federal Trade Commission

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088764

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NDA 088764 describes PROMETH VC W/ CODEINE, which is a drug marketed by Actavis Mid Atlantic and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETH VC W/ CODEINE profile page.

The generic ingredient in PROMETH VC W/ CODEINE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 088764
Pharmacology for NDA: 088764
Suppliers and Packaging for NDA: 088764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETH VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088764 ANDA Bryant Ranch Prepack 63629-2959 63629-2959-1 120 mL in 1 BOTTLE (63629-2959-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;5MG/5ML;6.25MG/5ML
Approval Date:Oct 31, 1984TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Harvard Business School

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