Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040361
Company: BARR
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 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
01/31/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040361_dextroamphetamine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

01/29/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/29/2014 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040361Orig1s017ltr.pdf
02/06/2008 SUPPL-11 Labeling

Label is not available on this site.

08/31/2007 SUPPL-10 Labeling

Label is not available on this site.

02/14/2002 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/14/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2002 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/14/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2014 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf
03/29/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf
03/29/2014 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf
01/31/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Prntlbl.pdf

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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