Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200166
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVEKEO AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription AA No No
EVEKEO AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/09/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/17/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/12/2014 SUPPL-2 Labeling-Proprietary Name Change

Label is not available on this site.

EVEKEO

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 211139 AMNEAL PHARMS
EVEKEO AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 200166 ARBOR PHARMS LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 211139 AMNEAL PHARMS
EVEKEO AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 200166 ARBOR PHARMS LLC

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