Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Healthtrust
McKinsey
Mallinckrodt
Citi
McKesson
Fish and Richardson
AstraZeneca
Cerilliant

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206028

« Back to Dashboard

NDA 206028 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, Macleods Pharms Ltd, Silarx Pharms Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, 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-two NDAs. It is available from thirty-three 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-one 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 206028
Tradename:MEMANTINE HYDROCHLORIDE
Applicant:Lupin Ltd
Ingredient:memantine hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206028
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 206028
Suppliers and Packaging for NDA: 206028
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206028 ANDA Lupin Pharmaceuticals, Inc. 68180-246 N 68180-246-06
MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206028 ANDA Lupin Pharmaceuticals, Inc. 68180-246 N 68180-246-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7MG
Approval Date:Sep 28, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength14MG
Approval Date:Sep 28, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength21MG
Approval Date:Sep 28, 2016TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
Federal Trade Commission
Cipla
Deloitte
Citi
Dow
Boehringer Ingelheim
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.