Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021519
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUVOX | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LUVOX | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LUVOX | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021519s026lbl.pdf | |
| 09/20/2021 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf | |
| 12/16/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf | |
| 01/04/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf | |
| 07/18/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf | |
| 11/30/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf | |
| 03/16/2011 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf | |
| 02/24/2009 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf | |
| 12/20/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf |