Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050665
Company: CORDEN PHARMA
Company: CORDEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFZIL | CEFPROZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |
| CEFZIL | CEFPROZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/22/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf | |
| 09/14/2007 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf | |
| 06/23/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf |