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Generated: November 21, 2018

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Details for New Drug Application (NDA): 205122

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NDA 205122 describes QUDEXY XR, which is a drug marketed by Upsher-smith Labs and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QUDEXY XR profile page.

The generic ingredient in QUDEXY XR 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 205122
Tradename:QUDEXY XR
Applicant:Upsher-smith Labs
Ingredient:topiramate
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 NDA Upsher-Smith Laboratories, Inc. 0245-1071 0245-1071-30 1 BOTTLE in 1 CARTON (0245-1071-30) > 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 NDA Upsher-Smith Laboratories, Inc. 0245-1071 0245-1071-90 1 BOTTLE in 1 CARTON (0245-1071-90) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Mar 11, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 19, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 19, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 19, 2033Product Flag?YSubstance Flag?Delist Request?

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