Application 016059
- Type
- NDA
- Sponsor
- EGALET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDOCIN | INDOMETHACIN | CAPSULE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | INDOCIN | INDOMETHACIN | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80364 | SUPPL | 2024-11-25 |
| 80363 | SUPPL | 2024-11-25 |
| 80338 | SUPPL | 2024-11-25 |
| 67331 | SUPPL | 2021-05-03 |
| 67330 | SUPPL | 2021-05-03 |
| 67221 | SUPPL | 2021-04-29 |
| 58124 | SUPPL | 2019-03-28 |
| 58089 | SUPPL | 2019-03-27 |
| 58088 | SUPPL | 2019-03-27 |
| 33144 | SUPPL | 2016-05-11 |
| 12969 | SUPPL | 2016-05-11 |
| 10869 | SUPPL | 2016-05-11 |
| 414 | SUPPL | 2016-05-11 |
| 33143 | SUPPL | 2007-02-02 |
| 12968 | SUPPL | 2007-02-02 |
| 33142 | SUPPL | 2006-01-27 |
| 413 | SUPPL | 2005-03-29 |