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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 087128

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NDA 087128 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-eight 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-three suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.

Summary for 087128

Tradename:	MECLIZINE HYDROCHLORIDE
Applicant:	Apnar Pharma Lp
Ingredient:	meclizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 087128

Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists

Profile for product number 001

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

Profile for product number 002

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

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