Drugs@FDA: FDA-Approved Drugs
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STIE-CORT | HYDROCORTISONE | 2.5% | LOTION;TOPICAL | Prescription | AT | No | 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 |
---|---|---|---|---|---|---|---|
11/26/1985 | 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-15 | Labeling |
Label is not available on this site. |
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08/16/2001 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/03/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/14/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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01/17/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/17/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/14/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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09/14/1995 | SUPPL-7 | 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. |
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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. |
STIE-CORT
LOTION;TOPICAL; 2.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 2.5% | LOTION;TOPICAL | Prescription | No | AT | 040247 | TARO |
STIE-CORT | HYDROCORTISONE | 2.5% | LOTION;TOPICAL | Prescription | No | AT | 089074 | PADAGIS US |