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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 076306

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NDA 076306 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 fifty 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-four suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 076306

Tradename:	TOPIRAMATE
Applicant:	Roxane
Ingredient:	topiramate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 27, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 27, 2009	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 27, 2009	TE:		RLD:	No

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