APPLICATION
ANDA079172
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-19
LATEST ACTION
2024-10-15
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
2024-10-15Labeling · Supplement 24 · standardAP
2024-02-02Labeling · Supplement 18 · standardAP
2023-07-13Labeling · Supplement 7 · standardAP
2023-07-13Labeling · Supplement 14 · standardAP
2023-07-13Labeling · Supplement 10 · standardAP
2023-07-13Labeling · Supplement 15 · standardAP
2020-03-09Labeling · Supplement 1 · standardAP
2020-03-09Labeling · Supplement 2 · 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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