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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205622


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NDA 205622 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 205622
Tradename:RIVASTIGMINE
Applicant:Mylan Technologies
Ingredient:rivastigmine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205622
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 205622
Suppliers and Packaging for NDA: 205622
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 205622 ANDA Mylan Pharmaceuticals Inc. 0378-9070 0378-9070-93 30 POUCH in 1 CARTON (0378-9070-93) > 1 PATCH in 1 POUCH (0378-9070-16) > 24 h in 1 PATCH
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 205622 ANDA Mylan Pharmaceuticals Inc. 0378-9071 0378-9071-93 30 POUCH in 1 CARTON (0378-9071-93) > 1 PATCH in 1 POUCH (0378-9071-16) > 24 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Jun 20, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Jun 20, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Jun 20, 2018TE:ABRLD:No

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