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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201451


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NDA 201451 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, Chartwell Rx, Epic Pharma Llc, Invatech, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Strides Pharma, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-seven NDAs. It is available from twenty-eight 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 201451
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:meclizine hydrochloride
Patents:0
Pharmacology for NDA: 201451
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for 201451
Suppliers and Packaging for NDA: 201451
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 201451 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8462 0615-8462-39 30 TABLET in 1 BLISTER PACK (0615-8462-39)
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 201451 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8488 0615-8488-39 30 TABLET in 1 BLISTER PACK (0615-8488-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Feb 23, 2011TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 23, 2011TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 23, 2011TE:AARLD:No

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