Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090058

« Back to Dashboard
NDA 090058 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Global, Unichem Labs Ltd, Amneal Pharms, Mylan Pharms Inc, Lupin Ltd, Ajanta Pharma Ltd, Silarx Pharms Inc, Apotex Inc, Macleods Pharms Ltd, Upsher-smith Labs, Orchid Hlthcare, Bio-pharm Inc, Dr Reddys Labs Ltd, Teva Pharms, Puracap Pharm Llc, Torrent Pharms Ltd, Wockhardt Ltd, Aurobindo Pharma Ltd, Jubilant Generics, and Alembic Pharms Ltd, and is included in twenty-six NDAs. It is available from twenty-seven suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE profile page.

The generic ingredient in MEMANTINE HYDROCHLORIDE is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for NDA: 090058

Sun Pharma Global
memantine hydrochloride
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090058

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 090058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
memantine hydrochloride
TABLET;ORAL 090058 ANDA Sun Pharma Global FZE 47335-321 47335-321-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08)
memantine hydrochloride
TABLET;ORAL 090058 ANDA Sun Pharma Global FZE 47335-321 47335-321-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 5, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 5, 2010TE:ABRLD:No

Complete Access Available with Subscription
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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.