Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080693
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | AT | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/30/1976 | 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 |
---|---|---|---|---|---|
03/07/1996 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/10/1996 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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07/30/1987 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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02/10/1986 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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02/10/1986 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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02/10/1986 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1984 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1982 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCORTISONE
CREAM;TOPICAL; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALA-CORT | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | No | AT | 080706 | CROWN LABS |
HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | No | AT | 087795 | ACTAVIS MID ATLANTIC |
HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | Yes | AT | 080693 | FOUGERA PHARMS INC |