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Mallinckrodt
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McKesson
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Generated: April 19, 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 Bio Ag, and is included in seven NDAs. It is available from fourteen 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-two 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 N 60432-606-16
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 088875 ANDA Lohxa 70166-555 N 70166-555-05

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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Covington
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