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Serving leading biopharmaceutical companies globally:

McKesson
UBS
Baxter
Covington
Mallinckrodt
Harvard Business School
Cantor Fitzgerald
Farmers Insurance
Express Scripts
Fuji

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090961

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NDA 090961 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-one NDAs. It is available from thirty-four 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 090961
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090961
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 090961
Suppliers and Packaging for NDA: 090961
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090961 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-388 68382-388-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-388-10)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090961 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-388 68382-388-14 60 TABLET, FILM COATED in 1 BOTTLE (68382-388-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 10, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 10, 2017TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
Argus Health
US Army
Citi
Dow
Colorcon
Accenture
Merck
AstraZeneca

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