Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089414
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;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 |
---|---|---|---|---|---|---|---|
12/16/1986 | 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 |
---|---|---|---|---|---|
04/01/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/07/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/08/1995 | SUPPL-3 | 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 |