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Serving 500+ biopharmaceutical companies globally:

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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090073

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NDA 090073 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, Strides Pharma, Teva Pharms, Puracap Pharm Llc, Torrent Pharms Ltd, Zydus Pharms Usa Inc, Wockhardt Ltd, Aurobindo Pharma Ltd, Anchen Pharms, Jubilant Generics, and Alembic Pharms Ltd, and is included in thirty NDAs. It is available from twenty-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-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 NDA: 090073

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090073

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 090073

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 090073 ANDA Vivimed Labs Limited 62980-121 62980-121-01 30 TABLET in 1 BOTTLE (62980-121-01)
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL 090073 ANDA Vivimed Labs Limited 62980-121 62980-121-02 500 TABLET in 1 BOTTLE (62980-121-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 4, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 4, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Novartis
Mallinckrodt
Argus Health
Daiichi Sankyo
Chubb
Accenture
Express Scripts
UBS
Johnson and Johnson

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.

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