APPLICATION
ANDA076477
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-30
LATEST ACTION
2024-12-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATORVASTATIN CALCIUMDiscontinued
ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMDiscontinued
ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMDiscontinued
ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMDiscontinued
ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
Approval history
2024-12-04Labeling · Supplement 33 · standardAP
2023-03-15Labeling · Supplement 31 · standardAP
2021-06-08Labeling · Supplement 26 · standardAP
2021-06-08Labeling · Supplement 12 · standardAP
2021-06-08Labeling · Supplement 10 · standardAP
2021-06-08Labeling · Supplement 27 · standardAP
2021-06-08Labeling · Supplement 17 · standardAP
2021-06-08Labeling · Supplement 23 · standardAP
2021-06-08Labeling · Supplement 15 · standardAP
2015-10-06Labeling · Supplement 7 · standardAP
2014-09-23Labeling · Supplement 6 · standardAP
2013-01-27Labeling · Supplement 5 · standardAP
2012-04-20Labeling · Supplement 3AP
2012-01-17Manufacturing (CMC) · Supplement 1AP
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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