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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 077868

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NDA 077868 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 077868

Tradename:	TOPIRAMATE
Applicant:	Watson Labs
Ingredient:	topiramate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Apr 15, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Apr 15, 2009	TE:		RLD:	No

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