Last Updated: September 29, 2026

Details for New Drug Application (NDA): 217795

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NDA 217795 describes TOPIRAMATE, which is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Amta, Ascent Pharms Inc, Biocon Pharma, Dr Reddys, Glenmark Pharms Ltd, Lupin, Ph Health, Riconpharma Llc, 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-two NDAs. It is available from forty-seven suppliers. Additional details are available on the TOPIRAMATE profile page.

The generic ingredient in TOPIRAMATE is topiramate. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 217795

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

Pharmacology for NDA: 217795

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: 217795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	SOLUTION;ORAL	217795	ANDA	Ascend Laboratories, LLC	67877-833	67877-833-47	473 mL in 1 BOTTLE (67877-833-47)
TOPIRAMATE	topiramate	SOLUTION;ORAL	217795	ANDA	Ascend Laboratories, LLC	67877-833	67877-833-61	1 BOTTLE in 1 CARTON (67877-833-61) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	25MG/ML
Approval Date:	Oct 31, 2024	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Jan 5, 2026
Regulatory Exclusivity Use:	PATENT CHALLENGE

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