Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080400
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | 0.5% | CREAM;TOPICAL | Discontinued | None | No | No |
| HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Discontinued | None | No | No |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 09/15/1972 | 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 |
|---|---|---|---|---|---|
| 07/01/1988 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |