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Serving leading biopharmaceutical companies globally:

Deloitte
Dow
AstraZeneca
McKinsey
Cantor Fitzgerald
Argus Health
Mallinckrodt
Farmers Insurance
Harvard Business School
Johnson and Johnson

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206855

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NDA 206855 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-five 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 206855
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Puracap Pharm Llc
Ingredient:memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206855
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 206855
Suppliers and Packaging for NDA: 206855
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 206855 ANDA PuraCap Pharmaceutical LLC 51013-303 E 51013-303-22
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 206855 ANDA PuraCap Pharmaceutical LLC 51013-304 E 51013-304-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 17, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 17, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Argus Health
Colorcon
Chinese Patent Office
Fish and Richardson
AstraZeneca
QuintilesIMS
Queensland Health
Moodys

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