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Last Updated: November 22, 2024

Suppliers and packages for tradename: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

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PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	090575	ANDA	Amneal Pharmaceuticals LLC	65162-680-86	118 mL in 1 BOTTLE (65162-680-86)	2011-03-04
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	090575	ANDA	Amneal Pharmaceuticals LLC	65162-680-90	473 mL in 1 BOTTLE (65162-680-90)	2011-03-04
Ani Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	011265	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-758-04	118 mL in 1 BOTTLE (62559-758-04)	2024-09-05
Ani Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	011265	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-758-16	473 mL in 1 BOTTLE (62559-758-16)	2024-09-05
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	091687	ANDA	Tris Pharma Inc	27808-057-01	473 mL in 1 BOTTLE, PLASTIC (27808-057-01)	2014-01-31
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	091687	ANDA	A-S Medication Solutions	50090-6755-0	473 mL in 1 BOTTLE, PLASTIC (50090-6755-0)	2014-01-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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