Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018751
Company: ALVOGEN
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPECTAZOLE | ECONAZOLE NITRATE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/21/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf | |
| 09/07/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf | |
| 03/28/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf |