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Generated: September 25, 2018

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Details for New Drug Application (NDA): 084975

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NDA 084975 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, Bundy, Epic Pharma Llc, Jubilant Cadista, Kv Pharm, Mylan Pharms Inc, Par Pharm, Rising Pharms, Sandoz, Superpharm, UDL, Vangard, and Watson Labs, and is included in thirty-four NDAs. It is available from forty 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. Forty-one suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 084975
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Ani Pharms Inc
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084975

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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