Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203158
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/04/2021 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/09/2025 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |