Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075958
Company: AKORN
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 2MG BASE/ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 09/04/2003 | 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 |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2017 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/27/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |