Last Updated: September 28, 2026

Details for New Drug Application (NDA): 091185

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NDA 091185 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Amta, Ascent Pharms Inc, Biocon Pharma, Dr Reddys, Glenmark Pharms Ltd, Lupin, Ph Health, Riconpharma Llc, 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-two NDAs. It is available from forty-seven suppliers. Additional details are available on the TOPIRAMATE profile page.

The generic ingredient in TOPIRAMATE 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 091185

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 25, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 25, 2013	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 25, 2013	TE:		RLD:	No

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