Last Updated: November 8, 2026

Details for New Drug Application (NDA): 218482

« Back to Dashboard

NDA 218482 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, Micro Labs, Ph Health, Riconpharma Llc, Xiamen Lp Pharm Co, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Pharmazone, Rubicon Research, 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-three 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 218482

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

Pharmacology for NDA: 218482

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: 218482

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	CAPSULE;ORAL	218482	ANDA	Ascend Laboratories, LLC	67877-868	67877-868-05	500 CAPSULE in 1 BOTTLE (67877-868-05)
TOPIRAMATE	topiramate	CAPSULE;ORAL	218482	ANDA	Ascend Laboratories, LLC	67877-868	67877-868-33	1 BLISTER PACK in 1 CARTON (67877-868-33) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Jun 13, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jun 13, 2024	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.