APPLICATION
ANDA209288
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2024-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
Approval history
2024-12-17Labeling · Supplement 17 · standardAP
2023-06-09Labeling · Supplement 14 · standardAP
2023-01-03Labeling · Supplement 10 · standardAP
2023-01-03Labeling · Supplement 4 · standardAP
2023-01-03Labeling · Supplement 13 · standardAP
2023-01-03Labeling · Supplement 7 · standardAP
2019-10-11Labeling · Supplement 1 · standardAP
2018-12-21UNKNOWN · 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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