Application 201011
- Type
- ANDA
- Sponsor
- NOSTRUM LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 10MG/5ML | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 20MG/5ML | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 100MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70408-358 | Morphine Sulfate Oral Solution | Morphine Sulfate Oral Solution | Nostrum Laboratories, Inc. | ANDA | Current |
| 70408-359 | Morphine Sulfate | Morphine Sulfate | Nostrum Laboratories, Inc. | ANDA | Current |
| 70408-746 | Morphine Sulfate Oral Solution CII | Morphine Sulfate | Nostrum Laboratories, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76127 | ORIG | 2023-11-03 |