APPLICATION
ANDA206070
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-04
LATEST ACTION
2024-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PITAVASTATIN CALCIUMPrescription
PITAVASTATIN CALCIUM EQ 4MG BASE · TABLET · ORAL
PITAVASTATIN CALCIUMPrescription
PITAVASTATIN CALCIUM EQ 1MG BASE · TABLET · ORAL
PITAVASTATIN CALCIUMPrescription
PITAVASTATIN CALCIUM EQ 2MG BASE · TABLET · ORAL
Approval history
2024-09-27Labeling · Supplement 5 · standardAP
2024-05-29Labeling · Supplement 1 · standardAP
2019-04-04UNKNOWN · 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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