Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006530
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AVC | SULFANILAMIDE | 15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;VAGINAL | Discontinued | None | Yes | No |
AVC | SULFANILAMIDE | 1.05GM | SUPPOSITORY;VAGINAL | Discontinued | None | No | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/18/2013 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf |