APPLICATION
ANDA212278
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-02
LATEST ACTION
2025-05-08
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
2025-05-08Labeling · Supplement 2 · standardAP
2022-02-02UNKNOWN · Original · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.