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Details for New Drug Application (NDA): 084976

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NDA 084976 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Superpharm, Vangard, Kv Pharm, Par Pharm, Pliva, Mylan Pharms Inc, Watson Labs, Sandoz, Amneal Pharms, Abc Holding, UDL, Ani Pharms Inc, Jubilant Cadista, Bundy, Ivax Sub Teva Pharms, Rising Pharms Inc, Anabolic, Nexgen Pharma Inc, and Epic Pharma Llc, 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 NDA: 084976

Ivax Sub Teva Pharms
meclizine hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Summary for product number 001

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

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