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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
QuintilesIMS
Express Scripts
McKinsey
Fish and Richardson
Fuji
Covington
Baxter

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200294

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NDA 200294 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 200294
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:meclizine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 200294
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for 200294
Suppliers and Packaging for NDA: 200294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 200294 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8052 N 0615-8052-39
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 200294 ANDA Apotheca Inc. 12634-424 N 12634-424-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Apr 13, 2012TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 13, 2012TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Argus Health
QuintilesIMS
Daiichi Sankyo
Cipla
McKinsey
Chinese Patent Office
Chubb

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