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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206318


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NDA 206318 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 seven 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. Twelve suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 206318
Tradename:RIVASTIGMINE
Applicant:Zydus Noveltech Inc
Ingredient:rivastigmine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206318
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 206318
Suppliers and Packaging for NDA: 206318
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 206318 ANDA Northstar Rx LLC. 16714-115 16714-115-02 30 POUCH in 1 CARTON (16714-115-02) > 24 h in 1 POUCH (16714-115-01)
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 206318 ANDA Northstar Rx LLC. 16714-116 16714-116-02 30 POUCH in 1 CARTON (16714-116-02) > 24 h in 1 POUCH (16714-116-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Mar 4, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Mar 4, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Mar 4, 2019TE:ABRLD:No

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