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Last Updated: October 24, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087128


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NDA 087128 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 087128
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Annora Pharma
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087128
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for 087128
Suppliers and Packaging for NDA: 087128
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 087128 ANDA Par Pharmaceutical, Inc. 49884-035 49884-035-01 100 TABLET in 1 BOTTLE (49884-035-01)
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 087128 ANDA Par Pharmaceutical, Inc. 49884-035 49884-035-10 1000 TABLET in 1 BOTTLE (49884-035-10)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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