Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089066
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STIE-CORT | HYDROCORTISONE | 1% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 11/25/1985 | 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 |
|---|---|---|---|---|---|
| 11/28/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/16/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/11/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |