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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210319


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NDA 210319 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-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-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 210319
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Seton Pharms
Ingredient:memantine hydrochloride
Patents:0
Pharmacology for NDA: 210319
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 210319
Suppliers and Packaging for NDA: 210319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride SOLUTION;ORAL 210319 ANDA Seton Pharmaceuticals 13925-540 13925-540-12 360 mL in 1 BOTTLE (13925-540-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2MG/ML
Approval Date:Aug 31, 2020TE:AARLD:No

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