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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 021366


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NDA 021366 describes CRESTOR, which is a drug marketed by IPR 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-nine suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 021366
Tradename:CRESTOR
Applicant:Ipr
Ingredient:rosuvastatin calcium
Patents:0
Pharmacology for NDA: 021366
Medical Subject Heading (MeSH) Categories for 021366
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:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 12, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 12, 2003TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Aug 12, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021366

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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