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Generated: December 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200155

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NDA 200155 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Anchen Pharms, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Sun Pharma Global, Zydus Pharms Usa Inc, Bio-pharm Inc, Lannett Co Inc, Macleods Pharms Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, Upsher Smith Labs, and Wockhardt Ltd, and is included in thirty-four NDAs. It is available from thirty-seven 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 200155
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Torrent Pharms Ltd
Ingredient:memantine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200155
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 200155
Suppliers and Packaging for NDA: 200155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 200155 ANDA Torrent Pharmaceuticals Limited 13668-222 13668-222-01 100 TABLET in 1 BOTTLE (13668-222-01)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 200155 ANDA Torrent Pharmaceuticals Limited 13668-222 13668-222-05 500 TABLET in 1 BOTTLE (13668-222-05)

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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