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 are twenty-six drug master file entries for this compound. Fifty-four 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 Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased 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:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Oct 26, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Oct 26, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 26, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020844

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-001	Oct 26, 1998	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-002	Oct 26, 1998	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-001	Oct 26, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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