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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202640


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NDA 202640 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 202640
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Usa
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202640
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for 202640
Suppliers and Packaging for NDA: 202640
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 202640 ANDA Aurobindo Pharma Limited 59651-807 59651-807-01 100 TABLET in 1 BOTTLE (59651-807-01)
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 202640 ANDA Aurobindo Pharma Limited 59651-807 59651-807-99 1000 TABLET in 1 BOTTLE (59651-807-99)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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