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Last Updated: December 12, 2025

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 Actavis Mid Atlantic, Amneal Pharms, Chartwell Rx, Cosette, Hikma, Pharm Assoc, Pharmobedient, and Quagen, and is included in eight NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
Summary for 200386
Tradename:PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Applicant:Cosette
Ingredient:codeine phosphate; promethazine hydrochloride
Patents:0
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
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 200386 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0065 17856-0065-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1) / 5 mL in 1 CUP, UNIT-DOSE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 200386 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0065 17856-0065-2 1 CUP, UNIT-DOSE in 1 BAG (17856-0065-2) / 5 mL in 1 CUP, UNIT-DOSE

Profile 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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