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McKesson
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US Army
Moodys
Healthtrust

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201451

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NDA 201451 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms Inc, Bundy, Epic Pharma Llc, Jubilant Cadista, Kv Pharm, Mylan Pharms Inc, Par Pharm, Rising Pharms Inc, Sandoz, Superpharm, UDL, Vangard, and Watson Labs, 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 201451
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:meclizine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
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 Major Pharmaceuticals 0904-6516 N 0904-6516-61
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 201451 ANDA Major Pharmaceuticals 0904-6517 N 0904-6517-61

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:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Feb 23, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Julphar
McKinsey
Chinese Patent Office
Express Scripts
Queensland Health
Moodys
Medtronic

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