APPLICATION
ANDA206434
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-31
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 5MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2026-07-16Labeling · Supplement 13 · standardAP
2024-11-19Labeling · Supplement 12 · standardAP
2024-01-05Labeling · Supplement 7 · standardAP
2024-01-05Labeling · Supplement 10 · standardAP
2024-01-05Labeling · Supplement 8 · standardAP
2020-03-12Labeling · Supplement 5 · standardAP
2020-03-12Labeling · Supplement 2 · standardAP
2016-10-31UNKNOWN · 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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