APPLICATION
ANDA090548
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-29
LATEST ACTION
2024-12-04
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
2024-12-04Labeling · Supplement 31 · standardAP
2023-07-25Labeling · Supplement 26 · standardAP
2023-07-25Labeling · Supplement 27 · standardAP
2023-07-25Labeling · Supplement 25 · standardAP
2019-11-04Labeling · Supplement 23 · standardAP
2019-01-17Labeling · Supplement 19 · standardAP
2018-06-07Labeling · Supplement 16 · standardAP
2018-06-07Labeling · Supplement 17 · standardAP
2015-10-06Labeling · Supplement 11 · standardAP
2015-04-28Labeling · Supplement 10 · standardAP
2015-04-06Labeling · Supplement 3 · 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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