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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040151

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NDA 040151 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 Bio Ag, 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 040151
Pharmacology for NDA: 040151
Ingredient-typePhenothiazines
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 040151
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 040151 ANDA Apotheca Inc 12634-909 N 12634-909-02
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 040151 ANDA Apotheca Inc 12634-909 N 12634-909-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;6.25MG/5ML
Approval Date:Aug 26, 1997TE:AARLD:No

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