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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207236


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NDA 207236 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-four NDAs. It is available from thirty-eight 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-two 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 207236
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:memantine hydrochloride
Patents:0
Pharmacology for NDA: 207236
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 207236
Suppliers and Packaging for NDA: 207236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 207236 ANDA Lannett Company, Inc. 0527-1221 0527-1221-05 500 TABLET in 1 BOTTLE, PLASTIC (0527-1221-05)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 207236 ANDA Lannett Company, Inc. 0527-1221 0527-1221-06 60 TABLET in 1 BOTTLE, PLASTIC (0527-1221-06)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Nov 10, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Nov 10, 2016TE:RLD:No

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