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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205825

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NDA 205825 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Anchen Pharms, Ani Pharms Inc, Apotex, Lupin Ltd, Mylan, Sun Pharm, Zydus Pharms, Lannett Co Inc, Macleods Pharms Ltd, Torrent, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Celltrion, Chartwell, Cspc Ouyi, Dr Reddys Labs Ltd, Hikma, Jubilant Generics, Ningbo, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Unichem Labs Ltd, and Upsher Smith Labs, and is included in thirty-seven NDAs. It is available from thirty-five 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 205825
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:memantine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205825
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 205825
Suppliers and Packaging for NDA: 205825
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205825 ANDA Amneal Pharmaceuticals LLC 65162-782 65162-782-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-782-03)
MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205825 ANDA Amneal Pharmaceuticals LLC 65162-782 65162-782-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-782-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7MG
Approval Date:Oct 12, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength14MG
Approval Date:Oct 12, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength21MG
Approval Date:Oct 12, 2016TE:ABRLD:No

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