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FDA NDA · NDA020702

LIPITOR

atorvastatin calcium

Sponsor: UPJOHN

APPLICATION
NDA020702
TYPE
NDA
ORIGINAL APPROVAL
1996-12-17
LATEST ACTION
2024-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LIPITOR · ReferencePrescription
ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
LIPITOR · ReferencePrescription
ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
LIPITOR · ReferencePrescription
ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
LIPITOR · ReferencePrescription
ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2024-04-02Labeling · Supplement 81 · standardLetterAP
2022-12-07Labeling · Supplement 79 · standardLabelAP
2020-11-16Labeling · Supplement 77 · standardLabelAP
2020-09-25Labeling · Supplement 78 · standardLetterAP
2019-11-27Labeling · Supplement 74 · standardLetterAP
2019-04-12Labeling · Supplement 73 · standardLetterAP
2018-08-10Labeling · Supplement 71 · standardLabelAP
2017-06-23Labeling · Supplement 69 · 901 requiredLetterAP
2017-06-23Efficacy · Supplement 67 · standardLetterAP
2015-03-11Labeling · Supplement 65 · standardLetterAP
2014-05-21Labeling · Supplement 64 · standardLetterAP
2012-11-30Manufacturing (CMC) · Supplement 61 · priorityAP
2012-10-31Labeling · Supplement 62 · 901 requiredLetterAP
2012-10-31Labeling · Supplement 63 · standardLabelAP
2012-02-28Labeling · Supplement 60 · unknownReviewAP
2009-06-17Labeling · Supplement 56 · standardReviewAP
2009-03-27Labeling · Supplement 57 · standardLetterAP
2007-09-26Labeling · Supplement 50 · standardLabelAP
2007-03-02Efficacy · Supplement 47 · unknownLabelAP
2007-01-16Labeling · Supplement 49 · standardLetterAP
2006-08-07Labeling · Supplement 44 · standardLabelAP
2006-06-23Labeling · Supplement 46 · standardPatient Package InsertAP
2005-10-11Labeling · Supplement 43 · standardLetterAP
2005-09-21Efficacy · Supplement 42 · unknownLetterAP
2004-07-30Efficacy · Supplement 39 · standardReviewAP
2004-05-24Labeling · Supplement 27 · standardReviewAP
2003-09-29Manufacturing (CMC) · Supplement 37 · priorityLabelAP
2003-05-12Labeling · Supplement 36 · standardReviewAP
2002-10-18Efficacy · Supplement 33 · standardLabelAP
2002-07-02Manufacturing (CMC) · Supplement 35 · priorityReviewAP
2002-04-22Labeling · Supplement 34 · standardLabelAP
2002-04-22Efficacy · Supplement 29 · standardLetterAP
2002-04-08Manufacturing (CMC) · Supplement 32 · priorityAP
2001-12-27Manufacturing (CMC) · Supplement 31 · priorityReviewAP
2001-12-27Manufacturing (CMC) · Supplement 30 · priorityReviewAP
2001-11-20Manufacturing (CMC) · Supplement 28 · priorityReviewAP
2001-06-08Efficacy · Supplement 25 · standardLabelAP
2000-11-14Manufacturing (CMC) · Supplement 24 · priorityReviewAP
2000-04-07Manufacturing (CMC) · Supplement 22 · priorityReviewAP
1999-12-22Manufacturing (CMC) · Supplement 20 · priorityAP
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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