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Serving leading biopharmaceutical companies globally:

McKesson
UBS
Julphar
Deloitte
Johnson and Johnson
Harvard Business School
Medtronic
Cerilliant
Chubb
AstraZeneca

Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206528

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NDA 206528 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 206528
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Ajanta Pharma Ltd
Ingredient:memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206528
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 206528
Suppliers and Packaging for NDA: 206528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 206528 ANDA Ajanta Pharma Limited 27241-070 27241-070-06 60 TABLET in 1 BOTTLE (27241-070-06)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 206528 ANDA Ajanta Pharma Limited 27241-071 27241-071-06 60 TABLET in 1 BOTTLE (27241-071-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 30, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 30, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Merck
Teva
Queensland Health
Boehringer Ingelheim
Baxter
Argus Health
Moodys
Johnson and Johnson
McKinsey

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