APPLICATION
ANDA211933
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-08
LATEST ACTION
2025-03-13
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
2025-03-13Labeling · Supplement 20 · standardAP
2023-07-10Labeling · Supplement 17 · standardAP
2022-11-08Labeling · Supplement 6 · standardAP
2022-11-08Labeling · Supplement 2 · standardAP
2019-10-25Labeling · Supplement 1 · standardAP
2019-02-08UNKNOWN · 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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