Last Updated: May 25, 2026

Details for New Drug Application (NDA): 020505


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NDA 020505 describes TOPAMAX, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the TOPAMAX profile page.

The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 020505
Tradename:TOPAMAX
Applicant:Janssen Pharms
Ingredient:topiramate
Patents:0
Pharmacology for NDA: 020505
Mechanism of ActionCytochrome P450 2C19 Inhibitors
Cytochrome P450 3A4 Inducers
Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity
Suppliers and Packaging for NDA: 020505
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPAMAX topiramate TABLET;ORAL 020505 NDA Janssen Pharmaceuticals, Inc. 50458-639 50458-639-65 60 TABLET, COATED in 1 BOTTLE (50458-639-65)
TOPAMAX topiramate TABLET;ORAL 020505 NDA Janssen Pharmaceuticals, Inc. 50458-640 50458-640-65 60 TABLET, COATED in 1 BOTTLE (50458-640-65)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 24, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 24, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Dec 24, 1996TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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