Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022256
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SAVELLA | MILNACIPRAN HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | None | Yes | No |
| SAVELLA | MILNACIPRAN HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | None | Yes | No |
| SAVELLA | MILNACIPRAN HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| SAVELLA | MILNACIPRAN HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2009 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022256s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2009/022256s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-28 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022256s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022256Orig1s028ltr.pdf | |
| 09/20/2021 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022256s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022256Orig1s025ltr.pdf | |
| 12/23/2022 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022256Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022256Orig1s024ltr.pdf | |
| 12/19/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022256Orig1s023ltr.pdf | |
| 12/30/2016 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s022ltr.pdf | |
| 09/06/2016 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s021ltr.pdf | |
| 06/17/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2015 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022256Orig1s019ltr.pdf | |
| 05/21/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2013 | SUPPL-16 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s016lbl.pdf | |
| 10/30/2013 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf | |
| 10/30/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf | |
| 12/06/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022256s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s013ltr.pdf | |
| 10/30/2012 | SUPPL-12 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s012ltr.pdf |
| 11/08/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s011ltr.pdf | |
| 04/26/2011 | SUPPL-10 | REMS-Assessment, REMS-Modified |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022256Orig1s010.pdf |
| 05/17/2010 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s006ltr.pdf | |
| 06/01/2010 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/02/2010 | SUPPL-4 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s004ltr.pdf | |
| 02/01/2010 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s002ltr.pdf | |
| 04/16/2009 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022256s028lbl.pdf | |
| 08/18/2023 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022256s028lbl.pdf | |
| 12/23/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022256Orig1s024lbl.pdf | |
| 09/20/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022256s025lbl.pdf | |
| 09/20/2021 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022256s025lbl.pdf | |
| 12/19/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf | |
| 12/30/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s022lbl.pdf | |
| 09/06/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s021lbl.pdf | |
| 01/29/2015 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf | |
| 01/29/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf | |
| 10/30/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf | |
| 10/30/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf | |
| 06/25/2013 | SUPPL-16 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s016lbl.pdf |
| 12/06/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022256s013lbl.pdf | |
| 11/08/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf | |
| 05/17/2010 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s006lbl.pdf | |
| 02/02/2010 | SUPPL-4 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf | |
| 02/01/2010 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf | |
| 04/16/2009 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf | |
| 04/16/2009 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf | |
| 01/14/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf |