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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Dow
Daiichi Sankyo
Farmers Insurance
Chubb
Merck
AstraZeneca
Federal Trade Commission
UBS

Generated: May 22, 2018

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 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 087128
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Par Pharm
Ingredient:meclizine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
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 Liberty Pharmaceuticals, Inc. 0440-1736 N 0440-1736-08
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 087128 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1554 N 0615-1554-30

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Teva
Julphar
Argus Health
Mallinckrodt
Covington
Moodys
Accenture

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