Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202861
Company: INTL MEDICATION SYS
Company: INTL MEDICATION SYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2021 | 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-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2025 | 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. |