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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 084092


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NDA 084092 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, Epic Pharma Llc, Invatech, Jubilant Cadista, Kv Pharm, Lupin Ltd, Rising, Sandoz, Strides Pharma, Superpharm, UDL, Vangard, Watson Labs, Wilshire Pharms Inc, and Zydus, and is included in thirty-seven NDAs. It is available from thirty-three 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-six suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 084092
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Invatech
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084092

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 22, 1989TE:AARLD:No

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