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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 084843

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NDA 084843 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, Heritage, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma Intl, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-seven NDAs. It is available from twenty-five 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-one suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.

Summary for 084843

Tradename:	MECLIZINE HYDROCHLORIDE
Applicant:	Sandoz
Ingredient:	meclizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084843

Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	May 22, 1989	TE:	AA	RLD:	No

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