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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 079162

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NDA 079162 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Amta, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Ph Health, Xiamen Lp Pharm Co, Zydus, Zydus Pharms, Anda Repository, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Rubicon Research, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Ascent Pharms 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 forty-nine NDAs. It is available from forty-three 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-seven suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 079162

Tradename:	TOPIRAMATE
Applicant:	Invagen Pharms
Ingredient:	topiramate
Patents:	0

Pharmacology for NDA: 079162

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: 079162

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	TABLET;ORAL	079162	ANDA	Proficient Rx LP	63187-228	63187-228-30	30 TABLET in 1 BOTTLE (63187-228-30)
TOPIRAMATE	topiramate	TABLET;ORAL	079162	ANDA	Proficient Rx LP	63187-228	63187-228-60	60 TABLET in 1 BOTTLE (63187-228-60)

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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