APPLICATION
ANDA206015
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-20
LATEST ACTION
2024-06-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PITAVASTATIN CALCIUMPrescription
PITAVASTATIN CALCIUM EQ 2MG BASE · TABLET · ORAL
PITAVASTATIN CALCIUMPrescription
PITAVASTATIN CALCIUM EQ 4MG BASE · TABLET · ORAL
PITAVASTATIN CALCIUMPrescription
PITAVASTATIN CALCIUM EQ 1MG BASE · TABLET · ORAL
Approval history
2024-06-11Labeling · Supplement 8 · standardAP
2023-06-02Labeling · Supplement 7 · standardAP
2023-06-02Labeling · Supplement 6 · standardAP
2020-06-24Labeling · Supplement 4 · standardAP
2020-06-24Labeling · Supplement 3 · 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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