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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207308


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NDA 207308 describes RIVASTIGMINE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Noveltech Inc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm, and Watson Labs, and is included in fifteen NDAs. It is available from eight suppliers. 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. Thirteen suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 207308
Tradename:RIVASTIGMINE
Applicant:Amneal Pharms
Ingredient:rivastigmine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207308
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 207308
Suppliers and Packaging for NDA: 207308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 207308 ANDA Amneal Pharmaceuticals LLC 65162-749 65162-749-34 30 PATCH in 1 CARTON (65162-749-34) > 24 h in 1 PATCH
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 207308 ANDA Amneal Pharmaceuticals LLC 65162-825 65162-825-34 30 PATCH in 1 CARTON (65162-825-34) > 24 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Jan 8, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Jan 8, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Jan 8, 2019TE:ABRLD:No

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