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FDA ANDA · ANDA209869

PRAVASTATIN SODIUM

Sponsor: BIOCON PHARMA

APPLICATION
ANDA209869
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-13
LATEST ACTION
2025-08-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 20MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVASTATIN SODIUMPrescription
PRAVASTATIN SODIUM 10MG · TABLET · ORAL

Approval history

2025-08-05Labeling · Supplement 13 · standardAP
2023-03-27Labeling · Supplement 7 · standardAP
2021-01-29Labeling · Supplement 3 · standardAP
2018-04-13UNKNOWN · Original · standard — Letter ↗AP
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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