Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090533
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 2.5MG TABLET;ORAL Prescription None No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 7.5MG TABLET;ORAL Prescription None No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG TABLET;ORAL Prescription None No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 20MG TABLET;ORAL Prescription None No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 30MG TABLET;ORAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/25/2011 ORIG-1 Approval

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-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/30/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

DEXTROAMPHETAMINE SULFATE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 202893 AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 203548 AVANTHI INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 040361 BARR
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 206588 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 204330 NOVEL LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 210059 NUVO PHARM
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 040436 SPECGX LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 202893 AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 203548 AVANTHI INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 040361 BARR
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 206588 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 204330 NOVEL LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 210059 NUVO PHARM
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 040436 SPECGX LLC

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