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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Merck
Julphar
Dow
Fuji
Chinese Patent Office
Argus Health
Cerilliant
Moodys

Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040654

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NDA 040654 describes PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Hi-tech Pharmacal and Vintage and is included in two NDAs. It is available from five suppliers. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040654
Pharmacology for NDA: 040654
Ingredient-typePhenothiazines
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 040654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040654 ANDA Par Pharmaceutical 0603-1587 N 0603-1587-58
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040654 ANDA Physicians Total Care, Inc. 54868-3935 E 54868-3935-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML;6.25MG/5ML
Approval Date:Dec 7, 2006TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Dow
QuintilesIMS
Colorcon
US Department of Justice
Medtronic
Cerilliant
Harvard Business School
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