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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, Teva Pharms, Puracap Pharm Llc, Torrent Pharms Ltd, Wockhardt Ltd, Aurobindo Pharma Ltd, Jubilant Generics, and Alembic Pharms Ltd, and is included in twenty-six NDAs. It is available from twenty-seven 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-six 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: 090043

Upsher-smith Labs
memantine hydrochloride
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
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
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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