← FDA DRUG APPROVALS

FDA NDA · NDA021366

CRESTOR

rosuvastatin

Sponsor: ASTRAZENECA

APPLICATION
NDA021366
TYPE
NDA
ORIGINAL APPROVAL
2003-08-12
LATEST ACTION
2026-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CRESTOR · ReferencePrescription
ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
CRESTOR · ReferencePrescription
ROSUVASTATIN CALCIUM EQ 5MG BASE · TABLET · ORAL
CRESTOR · ReferencePrescription
ROSUVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
CRESTOR · ReferencePrescription
ROSUVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2026-04-29Labeling · Supplement 47 · standard — Label ↗AP
2024-07-31Labeling · Supplement 46 · standard — Letter ↗AP
2023-07-27Labeling · Supplement 45 · standard — Letter ↗AP
2023-01-13Labeling · Supplement 44 · standard — Letter ↗AP
2023-01-13Labeling · Supplement 43 · standard — Letter ↗AP
2020-09-25Labeling · Supplement 42 · 901 required — Letter ↗AP
2020-05-21Labeling · Supplement 40 · standard — Label ↗AP
2020-05-21Labeling · Supplement 41 · standard — Label ↗AP
2018-11-09Labeling · Supplement 38 · standard — Label ↗AP
2017-08-04Labeling · Supplement 37 · 901 required — Label ↗AP
2016-05-27Efficacy · Supplement 33 · standard — Letter ↗AP
2015-11-20Efficacy · Supplement 31 · standard — Letter ↗AP
2015-06-01Labeling · Supplement 32 · standard — Letter ↗AP
2014-07-08Labeling · Supplement 30 · standard — Letter ↗AP
2013-08-07Labeling · Supplement 28 · standard — Label ↗AP
2013-08-07Labeling · Supplement 29 · standard — Letter ↗AP
2012-12-20Labeling · Supplement 26 · standard — Label ↗AP
2012-10-31Labeling · Supplement 27 · 901 required — Letter ↗AP
2012-10-31Labeling · Supplement 25 · standard — Letter ↗AP
2012-02-28Labeling · Supplement 24 · unknown — Letter ↗AP
2010-11-19Labeling · Supplement 21 · unknown — Label ↗AP
2010-02-08Efficacy · Supplement 16 · standard — Review ↗AP
2010-01-22Labeling · Supplement 18 · standard — Letter ↗AP
2009-10-15Efficacy · Supplement 17 · priority — Pediatric Written Request ↗AP
2009-03-27Labeling · Supplement 15 · standard — Letter ↗AP
2009-01-23Labeling · Supplement 14 · standard — Letter ↗AP
2008-11-06Efficacy · Supplement 13 · unknown — Letter ↗AP
2007-11-08Efficacy · Supplement 10 · unknown — Label ↗AP
2007-07-23Labeling · Supplement 11 · standard — Letter ↗AP
2005-03-02Labeling · Supplement 5 · standard — Label ↗AP
2003-08-12Type 1 - New Molecular Entity · Original · standard — Pediatric Written Request ↗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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