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Details for New Drug Application (NDA): 200386

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NDA 200386 describes PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, which is a drug marketed by Pharm Assoc, Hi Tech Pharma, Actavis Mid Atlantic, Wockhardt, Nostrum Labs Inc, Tris Pharma Inc, and Amneal Pharms, 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 suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.

Pharmacology for NDA: 200386

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 200386

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
codeine phosphate; promethazine hydrochloride
SYRUP;ORAL 200386 ANDA Tris Pharma Inc 27808-065 27808-065-01 237 mL in 1 BOTTLE, PLASTIC (27808-065-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;6.25MG/5ML
Approval Date:Jun 29, 2012TE:AARLD:No

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