Orange Book product

RIFAMPIN 600MG/VIAL

Orange Book ANDA 065421 · MYLAN LABORATORIES LTD · Prescription

Key facts

Proprietary name RIFAMPIN
Active ingredients RIFAMPIN
Strength 600MG/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA065421
Applicant holder MYLAN LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 22, 2008

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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