Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040361
Company: BARR
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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/13/2023 | SUPPL-31 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2022 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
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-Medication Guide, Labeling-Package Insert |
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. |
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| 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-Medication Guide | 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 | |
| 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 | 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 | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 040361 | BARR |
| 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 |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS 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 | 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 | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 040361 | BARR |
| 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 |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |