← FDA DRUG APPROVALS

FDA NDA · NDA020740

BAYCOL

Sponsor: BAYER PHARMS

APPLICATION
NDA020740
TYPE
NDA
ORIGINAL APPROVAL
1997-06-26
LATEST ACTION
2001-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BAYCOLDiscontinued
CERIVASTATIN SODIUM 0.05MG · TABLET · ORAL
BAYCOLDiscontinued
CERIVASTATIN SODIUM 0.8MG · TABLET · ORAL
BAYCOLDiscontinued
CERIVASTATIN SODIUM 0.3MG · TABLET · ORAL
BAYCOLDiscontinued
CERIVASTATIN SODIUM 0.1MG · TABLET · ORAL
BAYCOLDiscontinued
CERIVASTATIN SODIUM 0.4MG · TABLET · ORAL
BAYCOLDiscontinued
CERIVASTATIN SODIUM 0.2MG · TABLET · ORAL

Approval history

2001-05-21Labeling · Supplement 19 · standard — Review ↗AP
2001-05-10Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP
2001-03-30Labeling · Supplement 6 · standard — Review ↗AP
2001-02-27Manufacturing (CMC) · Supplement 17 · standardAP
2001-01-23Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
2000-11-06Labeling · Supplement 14 · standard — Review ↗AP
2000-07-21Efficacy · Supplement 8 · standard — Review ↗AP
2000-07-21Efficacy · Supplement 13 · standard — Review ↗AP
2000-07-03Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP
1999-12-22Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
1999-12-10Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
1999-08-23Manufacturing (CMC) · Supplement 5 · standardAP
1999-07-13Manufacturing (CMC) · Supplement 4 · standardAP
1999-05-24Efficacy · Supplement 2 · standard — Review ↗AP
1999-01-04Labeling · Supplement 3 · standard — Review ↗AP
1998-08-20Manufacturing (CMC) · Supplement 1 · standardAP
1997-06-26Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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