Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211764
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/04/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
HYDROCORTISONE VALERATE
OINTMENT;TOPICAL; 0.2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | No | AB | 211764 | COSETTE |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | No | AB | 211750 | GLENMARK PHARMS LTD |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | No | AB | 075043 | TARO |