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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020740
Company: BAYER PHARMS

Products on NDA 020740

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020740

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.html

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.html
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.html
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.html
08/20/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020740

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

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