Orange Book product

LOPINAVIR AND RITONAVIR 200MG;50MG

Orange Book ANDA 079074 · MYLAN LABORATORIES LTD · Prescription

Key facts

Proprietary name LOPINAVIR AND RITONAVIR
Active ingredients LOPINAVIR, RITONAVIR
Strength 200MG;50MG
Dosage form TABLET
Route ORAL
Application ANDA079074
Applicant holder MYLAN LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 7, 2024

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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