Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020381
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIASPAN | NIACIN | 375MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| NIASPAN | NIACIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| NIASPAN | NIACIN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| NIASPAN | NIACIN | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| NIASPAN TITRATION STARTER PACK | NIACIN | 375MG;500MG;750MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 05/02/2022 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020381s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020381Orig1s055ltr.pdf | |
| 09/09/2020 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020381s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020381Orig1s054ltr.pdf | |
| 10/28/2015 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2015 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020381Orig1s051ltr.pdf | |
| 05/27/2015 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2013 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2013 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078Orig1s015ltr.pdf | |
| 11/09/2010 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s043ltr.pdf | |
| 02/24/2010 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s042ltr.pdf | |
| 09/16/2009 | SUPPL-41 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf | |
| 09/16/2009 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf | |
| 03/26/2009 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s038ltr.pdf |
| 12/18/2007 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s034ltr.pdf | |
| 05/29/2008 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf |
| 04/04/2007 | SUPPL-27 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s027ltr.pdf |
| 04/11/2006 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020381s025ltr.pdf | |
| 09/09/2005 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s023ltr.pdf | |
| 06/08/2005 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s020ltr.pdf | |
| 09/05/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/2003 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20381se1-013ltr.pdf | |
| 11/24/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1999 | SUPPL-7 | Efficacy-New Dosing Regimen |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381s07ltr.pdf |
| 10/28/1999 | SUPPL-6 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381S6LTR.PDF |
| 08/24/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/02/2022 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020381s055lbl.pdf | |
| 09/09/2020 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020381s054lbl.pdf | |
| 04/27/2015 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf | |
| 02/21/2013 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf | |
| 11/09/2010 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf | |
| 02/24/2010 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf | |
| 09/16/2009 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf | |
| 09/16/2009 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf | |
| 09/16/2009 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf | |
| 12/18/2007 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf | |
| 04/11/2006 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf | |
| 09/09/2005 | SUPPL-23 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf | |
| 06/08/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf | |
| 01/31/2003 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf |