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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204403


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NDA 204403 describes RIVASTIGMINE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in fifteen NDAs. It is available from nine 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 204403
Tradename:RIVASTIGMINE
Applicant:Alvogen
Ingredient:rivastigmine
Patents:0
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 47781-304-03 30 POUCH in 1 CARTON (47781-304-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-304-11)
RIVASTIGMINE rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 204403 ANDA Alvogen Inc. 47781-305 47781-305-03 30 POUCH in 1 CARTON (47781-305-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-305-11)

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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