Last Updated: September 28, 2026

Details for New Drug Application (NDA): 020844


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NDA 020844 describes TOPAMAX SPRINKLE, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TOPAMAX SPRINKLE profile page.

The generic ingredient in TOPAMAX SPRINKLE is topiramate. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 020844
Tradename:TOPAMAX SPRINKLE
Applicant:Janssen Pharms
Ingredient:topiramate
Patents:0
Pharmacology for NDA: 020844
Mechanism of ActionCytochrome P450 2C19 Inhibitors
Cytochrome P450 3A4 Inducers
Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity
Suppliers and Packaging for NDA: 020844
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPAMAX topiramate CAPSULE;ORAL 020844 NDA Janssen Pharmaceuticals, Inc. 50458-645 50458-645-65 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)
TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844 NDA Janssen Pharmaceuticals, Inc. 50458-645 50458-645-65 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Oct 26, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 26, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 26, 1998TE:RLD:Yes

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Preferred Citation:

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