Qudexy Xr

Treats partial-onset or primary generalized tonic-clonic seizures. NDA 205122, held by Upsher Smith Labs. Topiramate.

As of Nov 15, 2026, NDA 205122 (Qudexy Xr), held by Upsher Smith Labs, was first approved by FDA on Mar 11, 2014, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 11, 2014
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

QUDEXY XR is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older Preventive treatment of migraine in patients 12 years of age and older 1.1 Monotherapy Epilepsy QUDEXY XR is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Mar 29, 2017	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter Letter
Mar 29, 2017	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 30, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 11, 2014	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

5 strengths and forms


Qudexy Xr25MG · capsule, extended release;oral	Topiramate	RxReference drug
Qudexy Xr50MG · capsule, extended release;oral	Topiramate	RxReference drug
Qudexy Xr100MG · capsule, extended release;oral	Topiramate	RxReference drug
Qudexy Xr150MG · capsule, extended release;oral	Topiramate	RxReference drug
Qudexy Xr200MG · capsule, extended release;oral	Topiramate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Mar 6, 2026	Supplement 19Labeling · Standard review	Approved	Label Letter Medication Guide
Mar 12, 2025	Supplement 17Labeling · Standard review	Approved	Label Letter
Mar 28, 2024	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 2, 2022	Supplement 14Labeling · Standard review	Approved	Label Letter
Feb 4, 2022	Supplement 12Labeling · Standard review	Approved	Letter Label
Feb 18, 2021	Supplement 11Labeling · Standard review	Approved	Letter Label
Feb 14, 2020	Supplement 10Labeling · Standard review	Approved	Label Letter
Feb 21, 2019	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 29, 2017	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter Letter
Mar 29, 2017	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 16, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 30, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 11, 2014	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 205122
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters