Last Updated: September 24, 2026

Details for New Drug Application (NDA): 083784

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NDA 083784 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, Aurobindo Pharma Usa, Bundy, Chartwell Rx, Epic Pharma Llc, Heritage, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Sciegen Pharms, Senores Pharms, Strides Pharma Intl, 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 is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.

Summary for 083784

Tradename:	MECLIZINE HYDROCHLORIDE
Applicant:	Ivax Sub Teva Pharms
Ingredient:	meclizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 083784

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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