Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016059
Company: ZYLA LIFE SCIENCES
Company: ZYLA LIFE SCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOCIN | INDOMETHACIN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| INDOCIN | INDOMETHACIN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016059s101lbl.pdf | |
| 03/26/2019 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016059s100lbl.pdf | |
| 05/09/2016 | SUPPL-99 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf | |
| 05/09/2016 | SUPPL-99 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf | |
| 05/09/2016 | SUPPL-99 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf | |
| 05/09/2016 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf | |
| 05/09/2016 | SUPPL-98 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf | |
| 05/09/2016 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf | |
| 01/30/2007 | SUPPL-97 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf | |
| 01/26/2006 | SUPPL-96 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf |