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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 216683

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NDA 216683 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-six suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for 216683

Tradename:	TOPIRAMATE
Applicant:	Rubicon Research
Ingredient:	topiramate
Patents:	0

Pharmacology for NDA: 216683

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: 216683

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPIRAMATE	topiramate	CAPSULE;ORAL	216683	ANDA	Advagen Pharma Ltd	72888-228	72888-228-05	500 CAPSULE in 1 BOTTLE (72888-228-05)
TOPIRAMATE	topiramate	CAPSULE;ORAL	216683	ANDA	Advagen Pharma Ltd	72888-228	72888-228-12	120 CAPSULE in 1 BOTTLE (72888-228-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	May 27, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	May 27, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	May 27, 2025	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Feb 1, 2026
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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