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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-seven drug master file entries for this compound. Thirty-seven 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

rosuvastatin calcium
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
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)
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:Yes
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
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RE37314*PED► subscribe
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RE37314*PED► subscribe
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RE37314*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.