Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011522
Company: TEVA WOMENS
Company: TEVA WOMENS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADDERALL 10 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ADDERALL 12.5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ADDERALL 15 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ADDERALL 20 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ADDERALL 30 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ADDERALL 5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ADDERALL 7.5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/19/1960 | ORIG-1 | Approval | Type 2 New Active Ingredient and Type 4 New Combination | 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 |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011522s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011522Orig1s045ltr.pdf | |
| 02/25/2022 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/011522Orig1s044ltr.pdf | |
| 01/04/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011522s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011522Orig1s043ltr.pdf | |
| 10/01/2015 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s042ltr.pdf | |
| 04/17/2015 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s041ltr.pdf | |
| 06/07/2007 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011522s040ltr.pdf | |
| 07/26/2006 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf | |
| 07/26/2006 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf | |
| 08/02/2005 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf | |
| 08/02/2005 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf | |
| 11/08/2002 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11522scf030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/11-522S030_Adderall.cfm |
| 04/11/2002 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/12/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1998 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/13/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/13/1996 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/11522S010_Adderall.pdf |
| 02/13/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011522s045lbl.pdf | |
| 02/25/2022 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf | |
| 01/04/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011522s043lbl.pdf | |
| 10/01/2015 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf | |
| 04/17/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf | |
| 06/07/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf | |
| 07/26/2006 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf | |
| 07/26/2006 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf | |
| 08/02/2005 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf | |
| 08/02/2005 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf |