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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Chubb
Healthtrust
Daiichi Sankyo
Baxter
US Army
Novartis
Accenture
UBS
Boehringer Ingelheim

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040650

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NDA 040650 describes PROMETHAZINE WITH CODEINE, which is a drug marketed by Vintage and is included in one NDA. It is available from eleven suppliers. Additional details are available on the PROMETHAZINE WITH CODEINE profile page.

The generic ingredient in PROMETHAZINE WITH CODEINE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
Summary for 040650
Tradename:PROMETHAZINE WITH CODEINE
Applicant:Vintage
Ingredient:codeine phosphate; promethazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040650
Ingredient-typePhenothiazines
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 040650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE WITH CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 040650 ANDA Par Pharmaceutical 0603-1585 N 0603-1585-54
PROMETHAZINE WITH CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 040650 ANDA Par Pharmaceutical 0603-1585 N 0603-1585-58

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;6.25MG/5ML
Approval Date:Jan 31, 2006TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fish and Richardson
Johnson and Johnson
Cipla
Accenture
Chubb
Express Scripts
Medtronic
Cantor Fitzgerald

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