Application 202245
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CODEINE SULFATE | CODEINE SULFATE | SOLUTION;ORAL | 30MG/5ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84677 | SUPPL | 2026-01-06 |
| 84573 | SUPPL | 2025-12-29 |
| 80093 | SUPPL | 2024-11-04 |
| 77074 | SUPPL | 2023-12-19 |
| 77010 | SUPPL | 2023-12-19 |
| 76956 | SUPPL | 2023-12-18 |
| 76245 | ORIG | 2023-11-03 |
| 66639 | SUPPL | 2021-03-08 |
| 66638 | SUPPL | 2021-03-08 |
| 66576 | SUPPL | 2021-03-08 |
| 60412 | SUPPL | 2019-10-09 |
| 60411 | SUPPL | 2019-10-09 |
| 60376 | SUPPL | 2019-10-08 |
| 55720 | SUPPL | 2018-10-01 |
| 55719 | SUPPL | 2018-10-01 |
| 55572 | SUPPL | 2018-09-24 |
| 55571 | SUPPL | 2018-09-24 |
| 55570 | SUPPL | 2018-09-24 |
| 55569 | SUPPL | 2018-09-24 |
| 49634 | SUPPL | 2017-08-31 |
| 49616 | SUPPL | 2017-08-30 |
| 49615 | SUPPL | 2017-08-30 |
| 46427 | SUPPL | 2016-12-21 |
| 46304 | SUPPL | 2016-12-20 |
| 40143 | SUPPL | 2013-05-14 |
| 32215 | SUPPL | 2013-05-13 |
| 19301 | SUPPL | 2012-04-20 |
| 32214 | SUPPL | 2012-04-19 |
| 24411 | ORIG | 2012-02-13 |
| 22880 | ORIG | 2012-02-13 |
| 19300 | ORIG | 2011-07-06 |
| 9996 | ORIG | 2011-07-06 |