Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040436
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription AA 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
01/29/2002 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-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/28/2016 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/29/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/29/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/06/2008 SUPPL-5 Labeling

Label is not available on this site.

08/31/2007 SUPPL-4 Labeling

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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