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. Fifty-two 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 Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased 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:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 24, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 24, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Dec 24, 1996	TE:		RLD:	No

Expired US Patents for NDA 020505

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-003	Dec 24, 1996	7,018,983*PED	⤷ Subscribe
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996	7,498,311*PED	⤷ Subscribe
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-002	Dec 24, 1996	5,998,380*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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