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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 204326


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NDA 204326 describes ADZENYS XR-ODT, which is a drug marketed by Neos Theraps and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ADZENYS XR-ODT profile page.

The generic ingredient in ADZENYS XR-ODT is amphetamine. There are fifty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Summary for 204326
Tradename:ADZENYS XR-ODT
Applicant:Neos Theraps
Ingredient:amphetamine
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204326
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326 NDA Neos Therapeutics, LP 70165-005 70165-005-30 30 BLISTER PACK in 1 CARTON (70165-005-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326 NDA Neos Therapeutics, LP 70165-010 70165-010-30 30 BLISTER PACK in 1 CARTON (70165-010-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 204326
Tradename Dosage Ingredient NDA Submissiondate
ADZENYS XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL amphetamine 204326 2016-05-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrengthEQ 3.1MG BASE
Approval Date:Jan 27, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 9, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?

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