Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212367
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 09/11/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |