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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 206135


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NDA 206135 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Anchen Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Rising, Sun Pharm, Yichang Humanwell, Zydus Pharms, Lannett Co Inc, Macleods Pharms Ltd, Seton Pharms, Torrent, Ajanta Pharma Ltd, Alembic Pharms Ltd, Cadila, Celltrion, Chartwell, Dr Reddys Labs Ltd, Hikma, Jubilant Generics, Ningbo, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Renata, Strides Pharma, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in forty-one NDAs. It is available from thirty-two 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 206135
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Apotex
Ingredient:memantine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 206135

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7MG
Approval Date:Nov 22, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength14MG
Approval Date:Nov 22, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength21MG
Approval Date:Nov 22, 2016TE:ABRLD:No

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