Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085027
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 2.5% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
11/30/1977 | 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 |
---|---|---|---|---|---|
01/03/2000 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/18/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
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08/18/1999 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/18/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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06/18/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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08/14/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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06/11/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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06/02/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/07/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCORTISONE
OINTMENT;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% | OINTMENT;TOPICAL | Prescription | No | AT | 081203 | FOUGERA PHARMS INC |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | OINTMENT;TOPICAL | Prescription | No | AT | 085027 | PADAGIS US |