APPLICATION
ANDA206029
TYPE
ANDA
ORIGINAL APPROVAL
2023-11-20
LATEST ACTION
2023-11-20
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
2023-11-20UNKNOWN · Supplement 3 · standardAP
2023-11-20UNKNOWN · Supplement 1 · standardAP
2023-11-20UNKNOWN · Original · standardAP
2023-11-20UNKNOWN · Supplement 2 · 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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