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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/26/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/21/2001 | SUPPL-19 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S019_Baycol.pdf | |
05/10/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S018_Baycol.pdf | |
02/27/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/23/2001 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020740_S016_BAYCOL_TABLETS.pdf |
11/06/2000 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S014_Baycol.pdf |
07/21/2000 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm | |
07/03/2000 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020740_S012_BAYCOL.pdf |
12/22/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740_S010_BAYCOL.pdf |
07/21/2000 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm | |
12/10/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740s007.pdf |
03/30/2001 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20740S6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S006_Baycol.pdf | |
08/23/1999 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
07/13/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/04/1999 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S003_Baycol.pdf |
05/24/1999 | SUPPL-2 | Efficacy-New Dosing Regimen |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20740s02ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S002_Baycol.cfm |
08/20/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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.cfm |