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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
Johnson and Johnson
Argus Health

Generated: April 23, 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 two 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. Three 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
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

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:

Johnson and Johnson
Fish and Richardson
Boehringer Ingelheim
Queensland Health

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