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Last Updated: April 21, 2021

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Details for New Drug Application (NDA): 209063

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NDA 209063 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. Ten suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 209063
Tradename:RIVASTIGMINE
Applicant:Breckenridge
Ingredient:rivastigmine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209063
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 209063
Suppliers and Packaging for NDA: 209063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 209063 ANDA Breckenridge Pharmaceutical, Inc. 51991-897 51991-897-30 30 POUCH in 1 CARTON (51991-897-30) > 1 PATCH in 1 POUCH (51991-897-99) > 24 h in 1 PATCH
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 209063 ANDA Breckenridge Pharmaceutical, Inc. 51991-898 51991-898-30 30 POUCH in 1 CARTON (51991-898-30) > 1 PATCH in 1 POUCH (51991-898-99) > 24 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Nov 26, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Nov 26, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Nov 26, 2019TE:ABRLD:No

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