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Last Updated: March 20, 2025

Details for New Drug Application (NDA): 085195

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NDA 085195 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Invagen Pharms, Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma Usa, Bundy, Chartwell Rx, Epic Pharma Llc, Invatech, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Strides Pharma, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-seven NDAs. It is available from twenty-four suppliers. Additional details are available on the MECLIZINE HYDROCHLORIDE profile page.

The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.

Summary for 085195

Tradename:	MECLIZINE HYDROCHLORIDE
Applicant:	Watson Labs
Ingredient:	meclizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 085195

Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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