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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Cantor Fitzgerald
Queensland Health
Teva
Daiichi Sankyo
Moodys
Accenture
Federal Trade Commission
Boehringer Ingelheim

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090043

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NDA 090043 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: 090043

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

Pharmacology for NDA: 090043

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 090043

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 090043 ANDA Upsher-Smith Laboratories, Inc 0832-1112 0832-1112-60 60 TABLET, FILM COATED in 1 BOTTLE (0832-1112-60)
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 090043 ANDA Upsher-Smith Laboratories, Inc 0832-1113 0832-1113-60 60 TABLET, FILM COATED in 1 BOTTLE (0832-1113-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 31, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 31, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Baxter
Accenture
Chubb
QuintilesIMS
Julphar
Cantor Fitzgerald
Citi
Daiichi Sankyo
Chinese Patent Office
Colorcon

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