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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215663

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NDA 215663 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, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, 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-three 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 215663

Tradename:	TOPIRAMATE
Applicant:	Ajanta Pharma Ltd
Ingredient:	topiramate
Patents:	0

Pharmacology for NDA: 215663

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 215663

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	215663	ANDA	Ajanta Pharma USA Inc.	27241-227	27241-227-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-227-01)
TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	215663	ANDA	Ajanta Pharma USA Inc.	27241-227	27241-227-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-227-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Aug 15, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Aug 15, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Aug 15, 2023	TE:		RLD:	No

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