Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211827
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
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 |
---|---|---|---|---|---|---|---|
12/16/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211827Orig1s000ltr.pdf |
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 |