APPLICATION
ANDA207408
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-31
LATEST ACTION
2024-11-25
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
2024-11-25Labeling · Supplement 26 · standardAP
2023-11-22Labeling · Supplement 17 · standardAP
2023-11-22Labeling · Supplement 15 · standardAP
2023-11-22Labeling · Supplement 24 · standardAP
2023-11-22Labeling · Supplement 22 · standardAP
2019-04-03Labeling · Supplement 8 · standardAP
2019-04-03Labeling · 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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