You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 30, 2024

Details for New Drug Application (NDA): 208949

✉ Email this page to a colleague

« Back to Dashboard

NDA 208949 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 forty-eight 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-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 208949

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

Pharmacology for NDA: 208949

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: 208949

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208949	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1039	70710-1039-3	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3)
TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208949	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1039	70710-1039-9	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Nov 29, 2022	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Nov 29, 2022	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 29, 2022	TE:	AB2	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. 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.