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Last Updated: November 2, 2024

Suppliers and packages for generic ingredient: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

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DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

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
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0155-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0155-2)	2020-10-05
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	A-S Medication Solutions	50090-6585-0	118 mL in 1 BOTTLE (50090-6585-0)	2020-10-05
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	RPK Pharmaceuticals, Inc.	53002-4262-1	118 mL in 1 BOTTLE (53002-4262-1)	2020-10-05
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	Proficient Rx LP	63187-272-04	118 mL in 1 BOTTLE (63187-272-04)	2006-02-14
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	NuCare Pharmaceuticals,Inc.	68071-3551-4	118 mL in 1 BOTTLE (68071-3551-4)	2020-10-05
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	Preferred Pharmaceuticals Inc.	68788-8100-1	118 mL in 1 BOTTLE (68788-8100-1)	2021-10-08
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649	ANDA	Proficient Rx LP	71205-654-04	118 mL in 1 BOTTLE (71205-654-04)	2020-10-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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