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Details for New Drug Application (NDA): 090052

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NDA 090052 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, Macleods Pharms Ltd, Upsher-smith Labs, Orchid Hlthcare, Bio-pharm Inc, Dr Reddys Labs Ltd, Teva Pharms, Puracap Pharm Llc, Torrent Pharms Ltd, Wockhardt Ltd, Aurobindo Pharma Ltd, Jubilant Generics, and Alembic Pharms Ltd, and is included in twenty-five NDAs. It is available from twenty-five suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE profile page.

The generic ingredient in MEMANTINE HYDROCHLORIDE is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-five suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for NDA: 090052

Tradename:
MEMANTINE HYDROCHLORIDE
Applicant:
Teva Pharms
Ingredient:
memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 25, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 25, 2011TE:ABRLD:No


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