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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Daiichi Sankyo

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088761

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NDA 088761 describes PROMETH VC PLAIN, which is a drug marketed by G And W Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETH VC PLAIN profile page.

The generic ingredient in PROMETH VC PLAIN is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 088761
Applicant:G And W Labs Inc
Ingredient:phenylephrine hydrochloride; promethazine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 088761
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 088761
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETH VC PLAIN phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088761 ANDA Bryant Ranch Prepack 63629-1868 63629-1868-1 120 mL in 1 BOTTLE (63629-1868-1)
PROMETH VC PLAIN phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088761 ANDA Bryant Ranch Prepack 63629-1868 63629-1868-2 240 mL in 1 BOTTLE (63629-1868-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML;6.25MG/5ML
Approval Date:Nov 8, 1984TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office
US Army
US Department of Justice
Cantor Fitzgerald

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