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FDA ANDA · ANDA206047

PITAVASTATIN CALCIUM

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA206047
TYPE
ANDA
ORIGINAL APPROVAL
2023-02-22
LATEST ACTION
2024-06-11
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

2024-06-11Labeling · Supplement 2 · standardAP
2023-02-22UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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