Drugs@FDA: FDA-Approved Drugs
Company: ZYLA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOCIN SR | INDOMETHACIN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/23/1982 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
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-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018185s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018185Orig1s058ltr.pdf | |
| 03/26/2019 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018185s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018185Orig1s057ltr.pdf | |
| 05/09/2016 | SUPPL-56 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf | |
| 05/09/2016 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf | |
| 10/11/2001 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 10/07/1997 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1996 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 10/24/1994 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/13/1994 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1994 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 05/25/1989 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 01/09/1989 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/10/1988 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/03/1988 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/19/1986 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/27/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/30/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1984 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/03/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/31/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/05/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/01/1983 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/19/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/01/1983 | SUPPL-2 | 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-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018185s058lbl.pdf | |
| 03/26/2019 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018185s057lbl.pdf | |
| 05/09/2016 | SUPPL-56 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf | |
| 05/09/2016 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf | |
| 05/09/2016 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf | |
| 05/09/2016 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf |