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Serving leading biopharmaceutical companies globally:

Covington
Harvard Business School
Citi
Colorcon
Novartis
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Medtronic
Express Scripts
US Army

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090051

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NDA 090051 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Global, Unichem Labs Ltd, Amneal Pharms, Mylan Pharms Inc, Lupin Ltd, Ajanta Pharma Ltd, Silarx Pharms Inc, Apotex Inc, Macleods Pharms Ltd, Upsher-smith Labs, Orchid Hlthcare, Bio-pharm Inc, Dr Reddys Labs Ltd, Strides Pharma, Teva Pharms, Puracap Pharm Llc, Torrent Pharms Ltd, Zydus Pharms Usa Inc, Wockhardt Ltd, Aurobindo Pharma Ltd, Anchen Pharms, Jubilant Generics, and Alembic Pharms Ltd, and is included in thirty-one NDAs. It is available from thirty-one 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 NDA: 090051

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090051

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 090051

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 090051 ANDA Lupin Pharmaceuticals, Inc. 68180-229 68180-229-07 60 TABLET, FILM COATED in 1 BOTTLE (68180-229-07)
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 090051 ANDA Lupin Pharmaceuticals, Inc. 68180-229 68180-229-13 10 BLISTER PACK in 1 CARTON (68180-229-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-229-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 10, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 10, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
Federal Trade Commission
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