Application 204223
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 2MG/ML (2MG/ML) | Yes | Yes |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 4MG/ML (4MG/ML) | Yes | Yes |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5MG/ML (5MG/ML) | Yes | Yes |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 8MG/ML (8MG/ML) | Yes | Yes |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10MG/ML (10MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-451 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-451 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-451 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-452 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-452 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-452 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-454 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-454 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-454 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-455 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-455 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-455 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-458 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-458 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-458 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-004 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-005 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-006 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-007 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
| 76045-008 | Morphine Sulfate | Morphine Sulfate | Fresenius Kabi, USA LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84657 | SUPPL | 2026-01-06 |
| 84576 | SUPPL | 2025-12-29 |
| 77056 | SUPPL | 2023-12-19 |
| 76957 | SUPPL | 2023-12-18 |
| 60502 | SUPPL | 2019-10-09 |
| 60459 | SUPPL | 2019-10-09 |
| 46438 | SUPPL | 2016-12-21 |
| 46432 | SUPPL | 2016-12-21 |
| 24462 | ORIG | 2014-03-06 |
| 22947 | ORIG | 2014-03-06 |
| 10307 | ORIG | 2013-11-06 |
| 19534 | ORIG | 2013-10-31 |