Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078396
Company: MEITHEAL
Company: MEITHEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078396s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/09/2022 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/09/2022 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/09/2022 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/29/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |