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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
AstraZeneca
Novartis
Dow
Mallinckrodt
Queensland Health
Cerilliant
Deloitte
Baxter

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088875

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NDA 088875 describes PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Hi Tech Pharma, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, and Wockhardt, and is included in seven NDAs. It is available from twelve suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 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 088875
Pharmacology for NDA: 088875
Ingredient-typePhenothiazines
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 088875
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 088875 ANDA Morton Grove Pharmaceuticals, Inc. 60432-606 60432-606-16 473 mL in 1 BOTTLE, PLASTIC (60432-606-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;6.25MG/5ML
Approval Date:Dec 17, 1984TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
Healthtrust
Baxter
Merck
Accenture
AstraZeneca
Fish and Richardson
US Army
Moodys

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