APPLICATION
ANDA207296
TYPE
ANDA
ORIGINAL APPROVAL
2024-11-06
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 8 · standardAP
2024-11-06UNKNOWN · 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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