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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 087122

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NDA 087122 describes METHDILAZINE HYDROCHLORIDE, which is a drug marketed by Alpharma Us Pharms and is included in one NDA. Additional details are available on the METHDILAZINE HYDROCHLORIDE profile page.

The generic ingredient in METHDILAZINE HYDROCHLORIDE is methdilazine hydrochloride. There are four drug master file entries for this compound. Additional details are available on the methdilazine hydrochloride profile page.

Summary for 087122

Tradename:	METHDILAZINE HYDROCHLORIDE
Applicant:	Alpharma Us Pharms
Ingredient:	methdilazine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	4MG/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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