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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 202640

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NDA 202640 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-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 suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 202640
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202640

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Sep 17, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Sep 17, 2012TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Sep 17, 2012TE:RLD:No

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