Details for New Drug Application (NDA): 011265

NDA 011265 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Hikma, and Tris Pharma Inc, and is included in four NDAs. It is available from five suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

Summary for 011265

Tradename:	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Applicant:	Ani Pharms
Ingredient:	dextromethorphan hydrobromide; promethazine hydrochloride
Patents:	0

Suppliers and Packaging for NDA: 011265

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	011265	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-758	62559-758-04	118 mL in 1 BOTTLE (62559-758-04)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	011265	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-758	62559-758-16	473 mL in 1 BOTTLE (62559-758-16)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Apr 2, 1984	TE:	AA	RLD:	Yes

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