APPLICATION
ANDA206465
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-21
LATEST ACTION
2025-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 5MG BASE · TABLET · ORAL
Approval history
2025-01-14Labeling · Supplement 16 · standardAP
2025-01-14Labeling · Supplement 17 · standardAP
2023-07-14Labeling · Supplement 14 · standardAP
2023-07-14Labeling · Supplement 9 · standardAP
2023-07-14Labeling · Supplement 15 · standardAP
2023-07-14Labeling · Supplement 8 · standardAP
2020-03-10Labeling · Supplement 2 · standardAP
2020-03-10Labeling · Supplement 1 · standardAP
2017-03-21UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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