Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211969
Company: UMEDICA
Company: UMEDICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EFINACONAZOLE | EFINACONAZOLE | 10% | SOLUTION;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/21/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/11/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
EFINACONAZOLE
SOLUTION;TOPICAL; 10%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EFINACONAZOLE | EFINACONAZOLE | 10% | SOLUTION;TOPICAL | Prescription | No | AB | 211827 | TEVA PHARMS USA |
EFINACONAZOLE | EFINACONAZOLE | 10% | SOLUTION;TOPICAL | Prescription | No | AB | 211969 | UMEDICA |
JUBLIA | EFINACONAZOLE | 10% | SOLUTION;TOPICAL | Prescription | Yes | AB | 203567 | BAUSCH |