Orange Book product

RIFADIN 600MG/VIAL

Orange Book NDA 050627 · SANOFI AVENTIS US LLC · Prescription

Key facts

Proprietary name RIFADIN
Active ingredients RIFAMPIN
Strength 600MG/VIAL
Dosage form INJECTABLE
Route INJECTION
Application NDA050627
Applicant holder SANOFI AVENTIS US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date May 25, 1989

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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