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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 217248

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NDA 217248 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Endo Operations, Glenmark Pharms Ltd, Lupin Ltd, Xiamen Lp Pharm Co, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Senores Pharms, 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, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt, and is included in forty-six NDAs. It is available from forty-eight 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. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 217248

Tradename:	TOPIRAMATE
Applicant:	Alkem Labs Ltd
Ingredient:	topiramate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Jun 20, 2023	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Jun 20, 2023	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Jun 20, 2023	TE:	AB1	RLD:	No

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