Details for New Drug Application (NDA): 021366
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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
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
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: | 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
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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