Application 018185
- Type
- NDA
- Sponsor
- EGALET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDOCIN SR | INDOMETHACIN | CAPSULE, EXTENDED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80370 | SUPPL | 2024-11-25 |
| 80369 | SUPPL | 2024-11-25 |
| 80276 | SUPPL | 2024-11-22 |
| 67298 | SUPPL | 2021-04-30 |
| 67297 | SUPPL | 2021-04-30 |
| 67231 | SUPPL | 2021-04-29 |
| 58126 | SUPPL | 2019-03-28 |
| 58085 | SUPPL | 2019-03-27 |
| 58084 | SUPPL | 2019-03-27 |
| 23116 | SUPPL | 2016-05-18 |
| 14942 | SUPPL | 2016-05-11 |
| 11180 | SUPPL | 2016-05-11 |
| 11179 | SUPPL | 2016-05-11 |
| 870 | SUPPL | 2016-05-11 |