Application 203158
- Type
- ANDA
- Sponsor
- NORTEC DEV ASSOC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | No | No |
| 006 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42689-005 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-006 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-007 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-008 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-009 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-010 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76475 | ORIG | 2023-11-07 |