Application 019999
- Type
- NDA
- Sponsor
- MERIDIAN MEDCL TECHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | INJECTABLE;INJECTION | 15MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 11704-235 | Morphine Sulfate | Morphine Sulfate | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-235 | Morphine Sulfate | Morphine Sulfate | Meridian Medical Technologies, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60421 | SUPPL | 2019-10-09 |
| 60277 | SUPPL | 2019-10-07 |
| 46249 | SUPPL | 2016-12-20 |
| 46248 | SUPPL | 2016-12-20 |
| 46192 | SUPPL | 2016-12-16 |
| 46191 | SUPPL | 2016-12-16 |