Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087457
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNACORT | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1981 | 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 |
|---|---|---|---|---|---|
| 02/27/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/02/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |