Last Updated: November 9, 2026

Details for New Drug Application (NDA): 007984

NDA 007984 describes AMBODRYL, which is a drug marketed by Parke Davis and is included in one NDA. Additional details are available on the AMBODRYL profile page.

The generic ingredient in AMBODRYL is bromodiphenhydramine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the bromodiphenhydramine hydrochloride profile page.

Summary for 007984

Tradename:	AMBODRYL
Applicant:	Parke Davis
Ingredient:	bromodiphenhydramine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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