APPLICATION
ANDA091650
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-17
LATEST ACTION
2023-04-25
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 20MG BASE · TABLET · ORAL
Approval history
2023-04-25Labeling · Supplement 24 · standardAP
2021-05-18Labeling · Supplement 18 · standardAP
2021-05-18Labeling · Supplement 19 · standardAP
2020-10-13Labeling · Supplement 16 · standardAP
2020-10-13Labeling · Supplement 17 · standardAP
2019-10-22Labeling · Supplement 13 · standardAP
2019-10-22Labeling · Supplement 11 · standardAP
2019-10-22Labeling · Supplement 15 · standardAP
2016-02-24Labeling · Supplement 7 · standardAP
2014-11-05Labeling · Supplement 5 · standardAP
2012-12-29Labeling · Supplement 2 · standardAP
2012-11-23Labeling · Supplement 1 · 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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