Application 022402
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CODEINE SULFATE | CODEINE SULFATE | TABLET;ORAL | 15MG | Yes | No |
| 002 | CODEINE SULFATE | CODEINE SULFATE | TABLET;ORAL | 30MG | Yes | No |
| 003 | CODEINE SULFATE | CODEINE SULFATE | TABLET;ORAL | 60MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0243 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0243 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0243 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0244 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0244 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0244 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0244 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0245 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0245 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0245 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-0245 | Codeine sulfate | codeine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84636 | SUPPL | 2026-01-05 |
| 84613 | SUPPL | 2025-12-31 |
| 80077 | SUPPL | 2024-11-04 |
| 77068 | SUPPL | 2023-12-19 |
| 77038 | SUPPL | 2023-12-19 |
| 76941 | SUPPL | 2023-12-18 |
| 76239 | ORIG | 2023-11-03 |
| 66617 | SUPPL | 2021-03-08 |
| 66616 | SUPPL | 2021-03-08 |
| 66565 | SUPPL | 2021-03-08 |
| 60391 | SUPPL | 2019-10-08 |
| 60390 | SUPPL | 2019-10-08 |
| 60379 | SUPPL | 2019-10-08 |
| 55706 | SUPPL | 2018-10-01 |
| 55705 | SUPPL | 2018-10-01 |
| 55594 | SUPPL | 2018-09-24 |
| 55593 | SUPPL | 2018-09-24 |
| 49636 | SUPPL | 2017-08-31 |
| 49611 | SUPPL | 2017-08-30 |
| 46377 | SUPPL | 2016-12-21 |
| 46336 | SUPPL | 2016-12-21 |
| 17322 | SUPPL | 2013-05-14 |
| 7331 | SUPPL | 2013-05-14 |
| 17321 | SUPPL | 2012-04-20 |
| 29684 | SUPPL | 2012-04-19 |
| 42508 | ORIG | 2009-12-30 |
| 24296 | ORIG | 2009-12-30 |
| 38661 | ORIG | 2009-07-24 |
| 29683 | ORIG | 2009-07-22 |