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FDA ANDA · ANDA204806

ATAZANAVIR SULFATE

atazanavir

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA204806
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-25
LATEST ACTION
2025-06-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 200MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 100MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 300MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2025-06-26Labeling · Supplement 13 · standardAP
2024-06-21Labeling · Supplement 12 · standardAP
2024-06-21Labeling · Supplement 8 · standardAP
2018-06-25UNKNOWN · OriginalLetterAP
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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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