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Serving leading biopharmaceutical companies globally:

Colorcon
Queensland Health
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200891

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NDA 200891 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 200891
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Alembic Pharms Ltd
Ingredient:memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200891
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 200891
Suppliers and Packaging for NDA: 200891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 200891 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-165 43353-165-53 60 TABLET, COATED in 1 BOTTLE (43353-165-53)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 200891 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-165 43353-165-18 3000 TABLET, COATED in 1 BOTTLE (43353-165-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 13, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 13, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Dow
Healthtrust
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Fuji
Cantor Fitzgerald
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Merck
Argus Health
Federal Trade Commission

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