Last Updated: June 10, 2026

Details for New Drug Application (NDA): 216167

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NDA 216167 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 216167

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Feb 9, 2023	TE:		RLD:	No

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