Drugs@FDA: FDA-Approved Drugs
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| INDOCIN | INDOMETHACIN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| INDOCIN | INDOMETHACIN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/10/1965 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016059s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016059Orig1s101ltr.pdf | |
| 03/26/2019 | SUPPL-100 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016059s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016059Orig1s100ltr.pdf | |
| 05/09/2016 | SUPPL-99 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf | |
| 05/09/2016 | SUPPL-98 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf | |
| 01/30/2007 | SUPPL-97 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf | |
| 01/26/2006 | SUPPL-96 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf | |
| 03/24/2005 | SUPPL-95 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf |
| 12/01/1997 | SUPPL-90 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1996 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-88 | Labeling |
Label is not available on this site. |
||
| 10/24/1994 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 09/13/1994 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-85 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1994 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 04/04/1991 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1989 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 01/09/1989 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 05/03/1988 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 06/03/1988 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 09/22/1986 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 11/27/1984 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 12/06/1984 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 06/25/1984 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1983 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/18/1983 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/03/1982 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1986 | SUPPL-45 | Efficacy |
Label is not available on this site. |
||
| 04/09/1981 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 07/29/1983 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1981 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 08/08/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1979 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1978 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1977 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/07/1981 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/27/1976 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| 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 |