APPLICATION
ANDA205519
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-19
LATEST ACTION
2026-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2026-04-28Labeling · Supplement 43 · standardAP
2026-01-22Manufacturing (CMC) · Supplement 44 · unknownAP
2023-03-08Labeling · Supplement 34 · standardAP
2022-10-25Labeling · Supplement 28 · standardAP
2021-05-27Labeling · Supplement 25 · standardAP
2021-05-27Labeling · Supplement 24 · standardAP
2020-07-01Labeling · Supplement 21 · standardAP
2019-10-21Labeling · Supplement 8 · standardAP
2019-10-21Labeling · Supplement 6 · standardAP
2019-10-21Labeling · Supplement 13 · standardAP
2019-10-21Labeling · Supplement 7 · standardAP
2019-10-21Labeling · Supplement 18 · 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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