Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
05/03/1983 | 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 |
---|---|---|---|---|---|
04/26/2001 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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12/27/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/21/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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06/28/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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04/15/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/12/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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06/12/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/12/1986 | SUPPL-2 | 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 |