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Generated: December 15, 2017

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 thirty-nine 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 suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.

Summary for 087128

Tradename:1
Applicant:1
Ingredient:1
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 0440-1736-08 8 TABLET in 1 BOTTLE, PLASTIC (0440-1736-08)
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 087128 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1554 0615-1554-39 30 TABLET in 1 BLISTER PACK (0615-1554-39)

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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