Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211851
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EFINACONAZOLE | EFINACONAZOLE | 10% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
12/16/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |