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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091585

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NDA 091585 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, Wockhardt Ltd, Aurobindo Pharma Ltd, Anchen Pharms, Jubilant Generics, and Alembic Pharms Ltd, and is included in twenty-nine NDAs. It is available from twenty-nine 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: 091585

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

Pharmacology for NDA: 091585

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 091585

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 091585 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-331 59746-331-05 500 TABLET, FILM COATED in 1 BOTTLE (59746-331-05)
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 091585 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-331 59746-331-10 1000 TABLET, FILM COATED in 1 BOTTLE (59746-331-10)

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Julphar
Harvard Business School
Citi
Express Scripts
Baxter
QuintilesIMS
Mallinckrodt
Covington
Colorcon
Farmers Insurance

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