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Serving leading biopharmaceutical companies globally:

Fuji
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Generated: December 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 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-three 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 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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Farmers Insurance
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