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Last Updated: October 14, 2024

Details for New Drug Application (NDA): 202840


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NDA 202840 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, Apozeal Pharms, Chartwell Molecular, Macleods Pharms Ltd, 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 202840
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Macleods Pharms Ltd
Ingredient:memantine hydrochloride
Patents:0
Pharmacology for NDA: 202840
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 202840
Suppliers and Packaging for NDA: 202840
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 202840 ANDA Macleods Pharmaceuticals Limited 33342-297 33342-297-09 60 TABLET in 1 BOTTLE (33342-297-09)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 202840 ANDA Macleods Pharmaceuticals Limited 33342-297 33342-297-12 10 BLISTER PACK in 1 CARTON (33342-297-12) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 13, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 13, 2015TE:ABRLD:No

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