← FDA DRUG APPROVALS

FDA ANDA · ANDA091677

LOPINAVIR AND RITONAVIR

Sponsor: HETERO LABS LTD III

APPLICATION
ANDA091677
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-04
LATEST ACTION
2021-06-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LOPINAVIR AND RITONAVIRPrescription
LOPINAVIR 100MG, RITONAVIR 25MG · TABLET · ORAL
LOPINAVIR AND RITONAVIRPrescription
LOPINAVIR 200MG, RITONAVIR 50MG · TABLET · ORAL

Approval history

2021-06-04Original — 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.

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 →