Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020740
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BAYCOL | CERIVASTATIN SODIUM | 0.05MG | TABLET;ORAL | Discontinued | None | No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.2MG | TABLET;ORAL | Discontinued | None | No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.3MG | TABLET;ORAL | Discontinued | None | No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.4MG | TABLET;ORAL | Discontinued | None | No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.8MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/21/2001 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf | |
| 05/10/2001 | SUPPL-18 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf |
| 03/30/2001 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf | |
| 07/21/2000 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf | |
| 07/21/2000 | SUPPL-8 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf | |
| 06/26/1997 | ORIG-1 | Approval | https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.html |