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Details for New Drug Application (NDA): 204403

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NDA 204403 describes RIVASTIGMINE, which is a drug marketed by Alvogen Malta, Watson Labs, Dr Reddys Labs Inc, Sun Pharm Inds, Macleods Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Orchid Hlthcare, and Alembic Pharms Ltd, and is included in nine NDAs. It is available from one supplier. 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. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the rivastigmine tartrate profile page.

Summary for NDA: 204403

Tradename:
RIVASTIGMINE
Applicant:
Alvogen Malta
Ingredient:
rivastigmine
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204403

Mechanism of ActionCholinesterase Inhibitors

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Sep 3, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Sep 3, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Aug 31, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Feb 29, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE


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