Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018851
Company: HERITAGE PHARMS
Company: HERITAGE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/18/1984 | ORIG-1 | Approval |
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-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018851Orig1s028ltr.pdf | |
| 05/09/2016 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018851Orig1s025ltr.pdf | |
| 08/07/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/04/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/16/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/25/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1985 | SUPPL-8 | Manufacturing (CMC) |
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-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf | |
| 04/28/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf | |
| 05/09/2016 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf | |
| 05/09/2016 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf |