APPLICATION
ANDA207752
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-31
LATEST ACTION
2025-04-10
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
2025-04-10Labeling · Supplement 26 · standardAP
2023-11-22Labeling · Supplement 19 · standardAP
2023-11-22Labeling · Supplement 17 · standardAP
2023-11-22Labeling · Supplement 13 · standardAP
2023-11-22Labeling · Supplement 10 · standardAP
2023-08-22Manufacturing (CMC) · Supplement 15 · unknownAP
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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