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Last Updated: August 13, 2020

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Details for New Drug Application (NDA): 085252

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NDA 085252 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms Inc, Aurex, Bundy, Epic Pharma Llc, Indicus Pharma, Invatech, Jubilant Cadista, Kv Pharm, Mylan Pharms Inc, Par Pharm, Rising, Sandoz, Superpharm, UDL, Vangard, Watson Labs, and Zydus, and is included in thirty-five NDAs. It is available from twenty-seven 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 085252
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Abc Holding
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 085252

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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