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Details for New Drug Application (NDA): 206855

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NDA 206855 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Global, Unichem Labs Ltd, Mylan Pharms Inc, Lupin Ltd, Ajanta Pharma Ltd, Silarx Pharms Inc, Macleods Pharms Ltd, Amneal Pharms, Upsher Smith, 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-three 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-four 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: 206855

Puracap Pharm Llc
memantine hydrochloride
Therapeutic Class:Antidementia Agents

Pharmacology for NDA: 206855

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 206855

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
memantine hydrochloride
TABLET;ORAL 206855 ANDA PuraCap Pharmaceutical LLC 51013-303 51013-303-22 60 TABLET in 1 BOTTLE (51013-303-22)
memantine hydrochloride
TABLET;ORAL 206855 ANDA PuraCap Pharmaceutical LLC 51013-304 51013-304-20 30 TABLET in 1 BOTTLE (51013-304-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 17, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 17, 2015TE:ABRLD:No

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