Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085025
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 2.5% | 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 |
---|---|---|---|---|---|---|---|
04/21/1983 | 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 |
---|---|---|---|---|---|
12/27/1999 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/08/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
05/08/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/11/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCORTISONE
CREAM;TOPICAL; 2.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALA-CORT | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 080706 | CROWN LABS |
ANUSOL HC | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 088250 | SALIX PHARMS |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 089682 | ACTAVIS MID ATLANTIC |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 089414 | FOUGERA PHARMS INC |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 085025 | PADAGIS US |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 040879 | RISING |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 088799 | TARO |