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Application 019917
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | INJECTABLE;INJECTION | 0.5MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-2028 | Morphine Sulfate | MORPHINE SULFATE | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60476 | SUPPL | 2019-10-09 |
| 60274 | SUPPL | 2019-10-07 |
| 46391 | SUPPL | 2016-12-21 |
| 46390 | SUPPL | 2016-12-21 |
| 46247 | SUPPL | 2016-12-20 |
| 46246 | SUPPL | 2016-12-20 |