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 |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf | |
| 01/29/2015 | SUPPL-19 | Labeling-Medication Guide | 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 |