Crestor

Lowers the risk of major adverse cardiovascular (CV) events (CV death, nonfatal…. NDA 21366, held by Astrazeneca. Rosuvastatin Calcium.

As of Nov 14, 2026, NDA 21366 (Crestor), held by Astrazeneca, was first approved by FDA on Aug 12, 2003, with 31 approved supplements and 0 published complete response letters.

First approved: Aug 12, 2003
Review: Standard
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CRESTOR is indicated:

To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for these events.
As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): ∘ in adults with hypercholesterolemia. ∘ and slow the progression of atherosclerosis in adults. ∘ in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). ∘ in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below


May 27, 2016	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 20, 2015	Supplement 31Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 8, 2010	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Summary Review Review Letter Label
Oct 15, 2009	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request
Nov 6, 2008	Supplement 13Efficacy (new indication or use)	Approved	Letter Label
Nov 8, 2007	Supplement 10Efficacy (new indication or use)	Approved	Other Other Review Letter
Aug 12, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Products

4 strengths and forms


CrestorEQ 5MG BASE · tablet;oral	Rosuvastatin Calcium	RxReference drug
CrestorEQ 10MG BASE · tablet;oral	Rosuvastatin Calcium	RxReference drug
CrestorEQ 20MG BASE · tablet;oral	Rosuvastatin Calcium	RxReference drug
CrestorEQ 40MG BASE · tablet;oral	Rosuvastatin Calcium	RxReference drug

All 32 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 48Labeling · Standard review	Approved	Label Letter
Apr 29, 2026	Supplement 47Labeling · Standard review	Approved	Label Letter
Jul 31, 2024	Supplement 46Labeling · Standard review	Approved	Review Letter Label
Jul 27, 2023	Supplement 45Labeling · Standard review	Approved	Label Letter
Jan 13, 2023	Supplement 44Labeling · Standard review	Approved	Letter Label
Jan 13, 2023	Supplement 43Labeling · Standard review	Approved	Letter
Sep 25, 2020	Supplement 42Labeling	Approved	Label Letter
May 21, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
May 21, 2020	Supplement 40Labeling · Standard review	Approved	Letter Label
Nov 9, 2018	Supplement 38Labeling · Standard review	Approved	Letter Label
Aug 4, 2017	Supplement 37Labeling	Approved	Letter Label
May 27, 2016	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 20, 2015	Supplement 31Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 1, 2015	Supplement 32Labeling · Standard review	Approved	Letter Label
Jul 8, 2014	Supplement 30Labeling · Standard review	Approved	Label Letter
Aug 7, 2013	Supplement 29Labeling · Standard review	Approved	Label Letter
Aug 7, 2013	Supplement 28Labeling · Standard review	Approved	Label Letter
Dec 20, 2012	Supplement 26Labeling · Standard review	Approved	Letter Label
Oct 31, 2012	Supplement 27Labeling	Approved	Letter Label
Oct 31, 2012	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 28, 2012	Supplement 24Labeling	Approved	Review Letter Label
Nov 19, 2010	Supplement 21Labeling	Approved	Label Letter
Feb 8, 2010	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Summary Review Review Letter Label
Jan 22, 2010	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 15, 2009	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request
Mar 27, 2009	Supplement 15Labeling · Standard review	Approved	Label Letter
Jan 23, 2009	Supplement 14Labeling · Standard review	Approved	Label Letter
Nov 6, 2008	Supplement 13Efficacy (new indication or use)	Approved	Letter Label
Nov 8, 2007	Supplement 10Efficacy (new indication or use)	Approved	Other Other Review Letter
Jul 23, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 2, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 12, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Identifiers

Application: NDA 21366
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters