← FDA DRUG APPROVALS

FDA ANDA · ANDA216168

DARUNAVIR

Sponsor: ANNORA PHARMA

APPLICATION
ANDA216168
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-21
LATEST ACTION
2025-01-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DARUNAVIRPrescription
DARUNAVIR 800MG · TABLET · ORAL
DARUNAVIRPrescription
DARUNAVIR 600MG · TABLET · ORAL

Approval history

2025-01-21UNKNOWN · Original · standardLetterAP
2025-01-21UNKNOWN · Original · standardLetterTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →