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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210278

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NDA 210278 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 210278

Tradename:	TOPIRAMATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	topiramate
Patents:	0

Pharmacology for NDA: 210278

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: 210278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	210278	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-370	68462-370-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-05)
TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	210278	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-370	68462-370-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Feb 1, 2021	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Feb 1, 2021	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Feb 1, 2021	TE:	AB2	RLD:	No

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