APPLICATION
ANDA079169
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-19
LATEST ACTION
2026-07-16
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
2026-07-16Labeling · Supplement 22 · standardAP
2025-01-14Labeling · Supplement 17 · standardAP
2025-01-14Labeling · Supplement 16 · standardAP
2023-07-13Labeling · Supplement 9 · standardAP
2023-07-13Labeling · Supplement 15 · standardAP
2023-07-13Labeling · Supplement 13 · standardAP
2023-07-13Labeling · Supplement 12 · standardAP
2020-04-07Labeling · Supplement 7 · standardAP
2020-04-07Labeling · Supplement 4 · 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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