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. |
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11/23/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |