Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020471
Company: CHIESI
Company: CHIESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYFLO | ZILEUTON | 300MG | TABLET;ORAL | Discontinued | None | No | No |
| ZYFLO | ZILEUTON | 600MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/08/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf | |
| 08/21/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf | |
| 09/28/2005 | SUPPL-11 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf |