Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211464
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
06/03/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211464Orig1s000ltr.pdf |