Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080505
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARMOL HC | HYDROCORTISONE ACETATE | 1% | 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 |
|---|---|---|---|---|---|---|---|
| 01/12/1973 | 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-18 | Labeling |
Label is not available on this site. |
||
| 11/23/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |