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FDA ANDA · ANDA212579

ATAZANAVIR

Sponsor: LAURUS

APPLICATION
ANDA212579
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-30
LATEST ACTION
2024-06-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 300MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 150MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2024-06-21Labeling · Supplement 3 · standardAP
2021-04-30UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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