Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074221
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMBELINE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/1995 | 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 |
|---|---|---|---|---|---|
| 02/13/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |