Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080473
Company: VALEANT INTL
Company: VALEANT INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYTONE | HYDROCORTISONE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |
| HYTONE | HYDROCORTISONE | 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/25/1972 | 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 |
|---|---|---|---|---|---|
| 03/27/2002 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |