Last Updated: June 10, 2026

Details for New Drug Application (NDA): 078462

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NDA 078462 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Amta, Ascent Pharms Inc, Dr Reddys, Glenmark Pharms Ltd, Lupin, Ph Health, Xiamen Lp Pharm Co, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Rubicon Research, Senores Pharms, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Hikma Pharms, Invagen Pharms, Natco, Pharmaco, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, and Unichem Labs Ltd, and is included in fifty NDAs. It is available from forty-six suppliers. Additional details are available on the TOPIRAMATE profile page.

The generic ingredient in TOPIRAMATE 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 078462

Tradename:	TOPIRAMATE
Applicant:	Aurobindo Pharma
Ingredient:	topiramate
Patents:	0

Pharmacology for NDA: 078462

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: 078462

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	TABLET;ORAL	078462	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8593	0615-8593-39	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8593-39)
TOPIRAMATE	topiramate	TABLET;ORAL	078462	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8594	0615-8594-39	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8594-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 27, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 27, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 27, 2009	TE:	AB	RLD:	No

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