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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Express Scripts
QuintilesIMS
Fish and Richardson
Daiichi Sankyo
Boehringer Ingelheim
Chubb
McKinsey

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090043

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NDA 090043 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Anchen Pharms, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Sun Pharma Global, Zydus Pharms Usa Inc, Bio-pharm Inc, Macleods Pharms Ltd, Silarx Pharms Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, Upsher-smith Labs, and Wockhardt Ltd, and is included in thirty-two NDAs. It is available from thirty-three suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE profile page.

The generic ingredient in MEMANTINE HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 090043
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Upsher-smith Labs
Ingredient:memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090043
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 090043
Suppliers and Packaging for NDA: 090043
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090043 ANDA Upsher-Smith Laboratories, Inc 0832-1112 N 0832-1112-60
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090043 ANDA Upsher-Smith Laboratories, Inc 0832-1113 N 0832-1113-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 31, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 31, 2015TE:ABRLD:No

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Cerilliant
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Dow
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US Department of Justice
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