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Serving 500+ biopharmaceutical companies globally:

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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205446

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NDA 205446 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 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: 205446

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

Pharmacology for NDA: 205446

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 205446

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
SOLUTION;ORAL 205446 ANDA Patrin Pharma 39328-551 39328-551-12 1 BOTTLE in 1 CARTON (39328-551-12) > 360 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2MG/ML
Approval Date:Dec 7, 2015TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Daiichi Sankyo
Fuji
QuintilesIMS
Argus Health
Teva
Deloitte
Moodys
US Army

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