Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085981
Company: X GEN PHARMS
Company: X GEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE ACETATE | HYDROCORTISONE ACETATE | 100% | POWDER;FOR RX COMPOUNDING | 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 |
---|---|---|---|---|---|---|---|
05/09/1978 | 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 |
---|---|---|---|---|---|
04/21/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/04/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |