APPLICATION
ANDA208850
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-16
LATEST ACTION
2024-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ROSUVASTATIN CALCIUMDiscontinued
ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMDiscontinued
ROSUVASTATIN CALCIUM EQ 5MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMDiscontinued
ROSUVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMDiscontinued
ROSUVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2024-11-15Labeling · Supplement 3 · standardAP
2024-11-15Labeling · Supplement 8 · standardAP
2024-11-15Labeling · Supplement 6 · standardAP
2024-11-15Labeling · Supplement 4 · standardAP
2020-04-07Labeling · Supplement 1 · 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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