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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 209905


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NDA 209905 describes EVEKEO ODT, which is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug. Additional details are available on the EVEKEO ODT profile page.

The generic ingredient in EVEKEO ODT is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 209905
Tradename:EVEKEO ODT
Applicant:Azurity
Ingredient:amphetamine sulfate
Patents:4

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Jan 30, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 19, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 10, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 10, 2037Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 209905

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-003 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-005 Apr 16, 2021 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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