Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017078
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1976 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/23/2025 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017078s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017078Orig1s059ltr.pdf | |
| 10/13/2023 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017078s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017078Orig1s055ltr.pdf | |
| 02/25/2022 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017078s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017078Orig1s054ltr.pdf | |
| 01/15/2019 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017078Orig1s052ltr.pdf | |
| 05/19/2017 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017078Orig1s050ltr.pdf | |
| 01/04/2017 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017078Orig1s049ltr.pdf | |
| 04/17/2015 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017078Orig1s048ltr.pdf | |
| 12/06/2013 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s047ltr.pdf | |
| 06/11/2013 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s046ltr.pdf | |
| 05/23/2008 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017078s044ltr.pdf | |
| 05/01/2007 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017078s042ltr.pdf | |
| 08/10/2006 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017078s040LTR.pdf | |
| 10/20/2000 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/2000 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1999 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/03/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/12/1994 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/16/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/02/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/25/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/25/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/22/1983 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/06/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/19/1980 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/29/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/29/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/29/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/30/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/27/1979 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/06/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/30/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/30/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/23/2025 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017078s059lbl.pdf | |
| 10/13/2023 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017078s055lbl.pdf | |
| 10/13/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017078s055lbl.pdf | |
| 02/25/2022 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017078s054lbl.pdf | |
| 01/15/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf | |
| 05/19/2017 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf | |
| 01/04/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf | |
| 04/17/2015 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf | |
| 12/06/2013 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf | |
| 06/11/2013 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf | |
| 05/23/2008 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf | |
| 05/01/2007 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf | |
| 08/10/2006 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf |
DEXEDRINE SPANSULE
CAPSULE, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 017078 | IMPAX LABS INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203901 | ACTAVIS ELIZABETH |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076353 | SPECGX LLC |
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 017078 | IMPAX LABS INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203901 | ACTAVIS ELIZABETH |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076353 | SPECGX LLC |
CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 017078 | IMPAX LABS INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203901 | ACTAVIS ELIZABETH |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076353 | SPECGX LLC |