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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Boehringer Ingelheim

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204403

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NDA 204403 describes RIVASTIGMINE, which is a drug marketed by Alvogen Malta, Ajanta Pharma Ltd, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds Ltd, and Watson Labs, and is included in eleven NDAs. It is available from one supplier. Additional details are available on the RIVASTIGMINE profile page.

The generic ingredient in RIVASTIGMINE is rivastigmine tartrate. There are thirty-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 204403
Applicant:Alvogen Malta
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204403
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 204403
Suppliers and Packaging for NDA: 204403
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 204403 ANDA Alvogen Inc. 47781-304 N 47781-304-03
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 204403 ANDA Alvogen Inc. 47781-305 N 47781-305-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Sep 3, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Sep 3, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Aug 31, 2015TE:ABRLD:No

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