APPLICATION
ANDA207453
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-23
LATEST ACTION
2024-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
Approval history
2024-09-27Labeling · Supplement 5 · standardAP
2024-09-27Labeling · Supplement 6 · standardAP
2020-03-10Labeling · Supplement 3 · standardAP
2020-03-10Labeling · Supplement 1 · standardAP
2020-03-10Labeling · Supplement 4 · standardAP
2016-11-23UNKNOWN · 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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