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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085253

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NDA 085253 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Anda Repository, Ani Pharms Inc, Bundy, Epic Pharma Llc, Indicus Pharma, Jubilant Cadista, Kv Pharm, Mylan Pharms Inc, Par Pharm, Sandoz, Superpharm, UDL, Vangard, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty-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-five suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 085253
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Abc Holding
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 085253

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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