Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Boehringer Ingelheim

Generated: April 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090044

« Back to Dashboard

NDA 090044 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, Lannett Co Inc, Macleods Pharms Ltd, Torrent, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Cspc Ouyi, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Unichem Labs Ltd, Upsher Smith Labs, and Wockhardt Ltd, and is included in thirty-four NDAs. It is available from thirty-nine 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 090044
Applicant:Orchid Hlthcare
Ingredient:memantine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 090044
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 090044
Suppliers and Packaging for NDA: 090044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090044 ANDA Orchid Chemicals & Pharmaceuticals Limited 68820-068 68820-068-09 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68820-068-09)
MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090044 ANDA Orchid Chemicals & Pharmaceuticals Limited 68820-068 68820-068-11 10 BLISTER PACK in 1 CARTON (68820-068-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68820-068-03) (68820-068-03)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Mar 12, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Mar 12, 2012TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Farmers Insurance
Chinese Patent Office

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.