← FDA DRUG APPROVALS

FDA ANDA · ANDA207407

LOPINAVIR AND RITONAVIR

Sponsor: LANNETT CO INC

APPLICATION
ANDA207407
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-27
LATEST ACTION
2020-04-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LOPINAVIR AND RITONAVIRDiscontinued
LOPINAVIR 80MG/ML, RITONAVIR 20MG/ML · SOLUTION · ORAL

Approval history

2020-04-27Labeling · Supplement 5 · standardAP
2020-04-27Labeling · Supplement 3 · standardAP
2020-04-27Labeling · Supplement 1 · standardAP
2020-04-27Labeling · Supplement 4 · standardAP
2020-04-27Labeling · Supplement 2 · standardAP
2016-12-27UNKNOWN · Original · standardLetterAP
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 →