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Details for New Drug Application (NDA): 020823

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NDA 020823 describes EXELON, which is a drug marketed by Novartis and is included in three NDAs. It is available from four suppliers. There are two patents protecting this drug and four Paragraph IV challenges. Additional details are available on the EXELON profile page.

The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the rivastigmine profile page.

Summary for NDA: 020823

Tradename:
EXELON
Applicant:
Novartis
Ingredient:
rivastigmine tartrate
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020823

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 020823

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXELON
rivastigmine tartrate
CAPSULE;ORAL 020823 NDA Novartis Pharmaceuticals Corporation 0078-0323 0078-0323-06 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0323-06) > 1 CAPSULE in 1 BLISTER PACK (0078-0323-61)
EXELON
rivastigmine tartrate
CAPSULE;ORAL 020823 NDA Novartis Pharmaceuticals Corporation 0078-0323 0078-0323-08 500 CAPSULE in 1 BOTTLE (0078-0323-08)

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Apr 21, 2000TE:ABRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Apr 21, 2000TE:ABRLD:No

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Apr 21, 2000TE:ABRLD:No

Expired Orange Book Patents for NDA: 020823

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-003Apr 21, 20004,948,807► subscribe
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-005Apr 21, 20004,948,807► subscribe
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-006Apr 21, 20004,948,807► subscribe
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