Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076654
Company: TARO PHARM INDS
Company: TARO PHARM INDS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
08/03/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076654lt.pdf |
HYDROCORTISONE BUTYRATE
CREAM;TOPICAL; 0.1%
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | No | AB1 | 076654 | TARO PHARM INDS |
LOCOID | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB1 | 018514 | BAUSCH |