Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022076
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOCOID | HYDROCORTISONE BUTYRATE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/18/2023 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022076s006lbl.pdf | |
| 10/30/2014 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022076s005lbl.pdf | |
| 05/18/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022076lbl.pdf |