Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076574
Company: ENCUBE
Company: ENCUBE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ECONAZOLE NITRATE | ECONAZOLE NITRATE | 1% | CREAM;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 |
---|---|---|---|---|---|---|---|
12/17/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076574_ORIGINAL APPROVAL_PACKAGE.pdf |