Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020740
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English