Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017814
Company: ZYLA LIFE SCIENCES
Company: ZYLA LIFE SCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOCIN | INDOMETHACIN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY;RECTAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/13/1984 | 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-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017814s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017814Orig1s044ltr.pdf | |
| 03/26/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017814s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017814Orig1s043ltr.pdf | |
| 05/09/2016 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf | |
| 05/09/2016 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf | |
| 01/30/2007 | SUPPL-40 | 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-39 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf | |
| 03/24/2005 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf |
| 02/04/2000 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1997 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/24/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/13/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/30/1994 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/23/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/09/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/10/1988 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/03/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/19/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/06/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/27/1984 | SUPPL-2 | Labeling |
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-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017814s044lbl.pdf | |
| 03/26/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017814s043lbl.pdf | |
| 05/09/2016 | SUPPL-42 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf | |
| 05/09/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf | |
| 01/30/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf | |
| 01/26/2006 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf |