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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 fourteen suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CRESTOR profile page.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are thirty-four drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for NDA: 021366

Tradename:
CRESTOR
Applicant:
Ipr
Ingredient:
rosuvastatin calcium
Patents:5
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 0310-0751 0310-0751-39 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0310-0751-39)
CRESTOR
rosuvastatin calcium
TABLET;ORAL 021366 NDA AstraZeneca Pharmaceuticals LP 0310-0751 0310-0751-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0751-90)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 12, 2003TE:ABRLD:No
Patent:6,316,460*PEDPatent Expiration:Feb 4, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:6,858,618*PEDPatent Expiration:Jun 17, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:7,030,152*PEDPatent Expiration:Oct 2, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021366

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RE37314*PED► subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RE37314*PED► subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RE37314*PED► subscribe
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