Application 018565
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DURAMORPH PF | MORPHINE SULFATE | INJECTABLE;INJECTION | 0.5MG/ML | Yes | Yes |
| 002 | DURAMORPH PF | MORPHINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | Yes | Yes |
| 003 | INFUMORPH | MORPHINE SULFATE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
| 004 | INFUMORPH | MORPHINE SULFATE | INJECTABLE;INJECTION | 25MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0641-6019 | Duramorph | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6019 | Duramorph | morphine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-6019 | Duramorph | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6019 | Duramorph | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6020 | Duramorph | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6020 | Duramorph | morphine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-6020 | Duramorph | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6020 | Duramorph | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6039 | INFUMORPH 200 | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6039 | INFUMORPH 200 | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6039 | INFUMORPH 200 | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6039 | INFUMORPH 200 | morphine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-6040 | INFUMORPH 500 | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6040 | INFUMORPH 500 | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6040 | INFUMORPH 500 | morphine sulfate | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6040 | INFUMORPH 500 | morphine sulfate | West-Ward Pharmaceuticals Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84649 | SUPPL | 2026-01-06 |
| 84648 | SUPPL | 2026-01-06 |
| 84557 | SUPPL | 2025-12-29 |
| 84556 | SUPPL | 2025-12-29 |
| 77037 | SUPPL | 2023-12-19 |
| 77036 | SUPPL | 2023-12-19 |
| 77035 | SUPPL | 2023-12-19 |
| 77034 | SUPPL | 2023-12-19 |
| 76974 | SUPPL | 2023-12-18 |
| 76973 | SUPPL | 2023-12-18 |
| 76951 | SUPPL | 2023-12-18 |
| 76950 | SUPPL | 2023-12-18 |
| 76554 | SUPPL | 2023-11-13 |
| 76546 | SUPPL | 2023-11-13 |
| 60414 | SUPPL | 2019-10-09 |
| 60276 | SUPPL | 2019-10-07 |
| 46509 | SUPPL | 2016-12-23 |
| 46489 | SUPPL | 2016-12-22 |
| 46403 | SUPPL | 2016-12-21 |
| 46220 | SUPPL | 2016-12-19 |
| 11239 | SUPPL | 2010-10-12 |
| 950 | SUPPL | 2010-10-05 |
| 33506 | SUPPL | 2009-05-19 |
| 11238 | SUPPL | 2005-06-08 |
| 949 | SUPPL | 2005-06-08 |
| 15032 | SUPPL | 2004-06-01 |
| 948 | SUPPL | 2003-07-06 |