← FDA DRUG APPROVALS

FDA NDA · NDA019766

ZOCOR

simvastatin

Sponsor: ORGANON

APPLICATION
NDA019766
TYPE
NDA
ORIGINAL APPROVAL
1991-12-23
LATEST ACTION
2023-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

ZOCOR · ReferenceDiscontinued
SIMVASTATIN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOCOR · ReferencePrescription
SIMVASTATIN 20MG · TABLET · ORAL
ZOCOR · ReferencePrescription
SIMVASTATIN 5MG · TABLET · ORAL
ZOCOR · ReferencePrescription
SIMVASTATIN 40MG · TABLET · ORAL
ZOCOR · ReferencePrescription
SIMVASTATIN 10MG · TABLET · ORAL

Approval history

2023-08-09Labeling · Supplement 104 · standardLetterAP
2023-03-14Labeling · Supplement 103 · standardLetterAP
2022-05-31Labeling · Supplement 102 · standardLetterAP
2022-03-07Labeling · Supplement 99 · standardLetterAP
2020-09-25Labeling · Supplement 101 · 901 requiredLetterAP
2019-10-04Labeling · Supplement 100 · standardLetterAP
2019-03-01Labeling · Supplement 92 · standardLetterAP
2018-02-28Labeling · Supplement 98 · standardLabelAP
2016-03-01Manufacturing (CMC) · Supplement 95 · standardAP
2015-02-02Labeling · Supplement 93 · standardLabelAP
2014-02-27Labeling · Supplement 91 · standardLabelAP
2013-10-25Labeling · Supplement 90 · standardLabelAP
2012-11-15Manufacturing (CMC) · Supplement 86 · standardAP
2012-10-31Labeling · Supplement 88 · 901 requiredLabelAP
2012-10-31Labeling · Supplement 87 · unknownLetterAP
2012-02-28Labeling · Supplement 85 · unknownLabelAP
2011-10-06Labeling · Supplement 83 · unknownReviewAP
2011-06-10Labeling · Supplement 79 · unknownLetterAP
2011-06-08Labeling · Supplement 82 · 901 requiredLetterAP
2011-06-08Labeling · Supplement 77 · standardReviewAP
2010-11-04Labeling · Supplement 81 · unknownLabelAP
2010-04-08Labeling · Supplement 80 · unknownLabelAP
2010-03-02Labeling · Supplement 78 · unknownLabelAP
2008-06-11Labeling · Supplement 76 · standardLabelAP
2007-11-26Labeling · Supplement 75 · standardLabelAP
2007-06-01Manufacturing (CMC) · Supplement 74LetterAP
2005-08-31Labeling · Supplement 69 · standardLabelAP
2005-05-17Labeling · Supplement 70 · standardLetterAP
2004-02-24Labeling · Supplement 67 · standardReviewAP
2004-02-24Labeling · Supplement 68 · standardLabelAP
2003-09-17Labeling · Supplement 65 · standardLabelAP
2003-09-17Labeling · Supplement 66 · standardLabelAP
2003-04-16Efficacy · Supplement 58 · standardReviewAP
2002-10-18Efficacy · Supplement 56 · standardLetterAP
2002-05-06Manufacturing (CMC) · Supplement 57 · standardAP
2002-05-06Labeling · Supplement 51 · standardLetterAP
2002-03-21Manufacturing (CMC) · Supplement 54 · standardReviewAP
2002-03-21Efficacy · Supplement 52 · standardLetterAP
2002-02-22Manufacturing (CMC) · Supplement 55 · standardReviewAP
2001-11-14Labeling · Supplement 53 · standardReviewAP
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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