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Medicines · US (FDA)

FDA 2025

FDA

Lopinavir and Ritonavir

Approved 11 Dec 2025OralTablet

The FDA lists this product in 12 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: LOPINAVIR 100MG; RITONAVIR 25MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

LOPINAVIR 100MG; RITONAVIR 25MG · TabletANDA079074-001 · Prescription
LOPINAVIR 200MG; RITONAVIR 50MG · TabletANDA079074-002 · Prescription
LOPINAVIR 100MG; RITONAVIR 25MG · TabletANDA091677-001 · Prescription
LOPINAVIR 200MG; RITONAVIR 50MG · TabletANDA091677-002 · Prescription
LOPINAVIR 200MG; RITONAVIR 50MG · TabletANDA204739-002 · Prescription
LOPINAVIR 100MG; RITONAVIR 25MG · TabletANDA204739-001 · Prescription
LOPINAVIR 80MG/ML; RITONAVIR 20MG/ML · SolutionANDA207407-001 · Discontinued
LOPINAVIR 100MG; RITONAVIR 25MG · TabletThis page
LOPINAVIR 200MG; RITONAVIR 50MG · TabletANDA214696-002 · Prescription
LOPINAVIR 40MG; RITONAVIR 10MG · Pellets

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

NDA205425-001 · Tentative approval

LOPINAVIR 100MG; RITONAVIR 25MG · TabletANDA213857-001 · Prescription

LOPINAVIR 200MG; RITONAVIR 50MG · TabletANDA213857-002 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA214696.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Lopinavir and Ritonavir
Active substance: lopinavir
Route: Oral
Dosage form: Tablet
Applicant: Micro Labs
Status: Prescription
FDA approval: 11 Dec 2025
Application: ANDA214696-001