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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 209905


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NDA 209905 describes EVEKEO ODT, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are two 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. Eight suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 209905
Tradename:EVEKEO ODT
Applicant:Arbor Pharms Llc
Ingredient:amphetamine sulfate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 209905
Suppliers and Packaging for NDA: 209905
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905 NDA Arbor Pharmaceuticals 24338-031 24338-031-01 1 CASE in 1 CARTON (24338-031-01) > 1 BLISTER PACK in 1 CASE (24338-031-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905 NDA Arbor Pharmaceuticals 24338-033 24338-033-01 1 CASE in 1 CARTON (24338-033-01) > 1 BLISTER PACK in 1 CASE (24338-033-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Jan 30, 2019TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 19, 2024Product Flag?YSubstance Flag?Delist Request?

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