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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 040659

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NDA 040659 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms, Annora Pharma, 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-four NDAs. It is available from thirty-one 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-three suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 040659
Applicant:Jubilant Cadista
Ingredient:meclizine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 040659
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for 040659
Suppliers and Packaging for NDA: 040659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 040659 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-901 35356-901-30 30 TABLET in 1 BOTTLE (35356-901-30)
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 040659 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-914 35356-914-30 30 TABLET in 1 BOTTLE (35356-914-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Jun 4, 2010TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 4, 2010TE:AARLD:No

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