Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076842
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | OINTMENT;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/27/2004 | ORIG-1 | Approval |
Label is not available on this site. |
HYDROCORTISONE BUTYRATE
OINTMENT;TOPICAL; 0.1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 076842 | TARO |