Details for New Drug Application (NDA): 009319

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NDA 009319 describes AMBENYL, which is a drug marketed by Forest Labs and is included in one NDA. Additional details are available on the AMBENYL profile page.

The generic ingredient in AMBENYL is bromodiphenhydramine hydrochloride; codeine phosphate. There are two drug master file entries for this compound. Additional details are available on the bromodiphenhydramine hydrochloride; codeine phosphate profile page.

Summary for 009319

Tradename:	AMBENYL
Applicant:	Forest Labs
Ingredient:	bromodiphenhydramine hydrochloride; codeine phosphate
Patents:	0

Profile for product number 006

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	12.5MG/5ML;10MG/5ML
Approval Date:	Jan 10, 1984	TE:		RLD:	No

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