Details for New Drug Application (NDA): 090575

NDA 090575 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 090575

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

Pharmacology for NDA: 090575

Mechanism of Action

Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Suppliers and Packaging for NDA: 090575

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	090575	ANDA	Amneal Pharmaceuticals LLC	65162-680	65162-680-86	118 mL in 1 BOTTLE (65162-680-86)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	090575	ANDA	Amneal Pharmaceuticals LLC	65162-680	65162-680-90	473 mL in 1 BOTTLE (65162-680-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	15MG/5ML;6.25MG/5ML
Approval Date:	Feb 8, 2011	TE:	AA	RLD:	No

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