APPLICATION
ANDA206084
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-26
LATEST ACTION
2021-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LYPQOZETPrescription
ATORVASTATIN CALCIUM EQ 40MG BASE, EZETIMIBE 10MG · TABLET · ORAL
LYPQOZETPrescription
ATORVASTATIN CALCIUM EQ 10MG BASE, EZETIMIBE 10MG · TABLET · ORAL
LYPQOZETPrescription
ATORVASTATIN CALCIUM EQ 80MG BASE, EZETIMIBE 10MG · TABLET · ORAL
LYPQOZETPrescription
ATORVASTATIN CALCIUM EQ 20MG BASE, EZETIMIBE 10MG · TABLET · ORAL
Approval history
2021-02-16Labeling · Supplement 2 · standardAP
2021-01-15Labeling · Supplement 3 · standardAP
2021-01-13Labeling · Supplement 4 · standardAP
2021-01-13Labeling · Supplement 5 · standardAP
2021-01-13Labeling · 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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