Application 017814
- Type
- NDA
- Sponsor
- EGALET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDOCIN | INDOMETHACIN | SUPPOSITORY;RECTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80340 | SUPPL | 2024-11-25 |
| 80297 | SUPPL | 2024-11-22 |
| 80296 | SUPPL | 2024-11-22 |
| 67335 | SUPPL | 2021-05-03 |
| 67334 | SUPPL | 2021-05-03 |
| 67225 | SUPPL | 2021-04-29 |
| 58125 | SUPPL | 2019-03-28 |
| 58087 | SUPPL | 2019-03-27 |
| 58086 | SUPPL | 2019-03-27 |
| 33352 | SUPPL | 2016-05-11 |
| 13910 | SUPPL | 2016-05-11 |
| 11068 | SUPPL | 2016-05-11 |
| 713 | SUPPL | 2016-05-11 |
| 33351 | SUPPL | 2007-02-02 |
| 13909 | SUPPL | 2007-02-02 |
| 11067 | SUPPL | 2006-01-27 |
| 712 | SUPPL | 2005-03-29 |