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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021366

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NDA 021366 describes CRESTOR, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the CRESTOR profile page.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for 021366

Tradename:	CRESTOR
Applicant:	Astrazeneca
Ingredient:	rosuvastatin calcium
Patents:	0

Pharmacology for NDA: 021366

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 021366

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 021366

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7560	0310-7560-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7560-90)
CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7570	0310-7570-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7570-90)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 12, 2003	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 12, 2003	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Aug 12, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021366

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	6,316,460*PED	⤷ Get Started Free
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	7,964,614*PED	⤷ Get Started Free
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	6,316,460*PED	⤷ Get Started Free
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	6,858,618*PED	⤷ Get Started Free
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	6,858,618*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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