Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019968
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ULTRAVATE | HALOBETASOL PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;TOPICAL | Discontinued | None | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/02/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf | |
09/17/2004 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf |