Orange Book product

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL

Orange Book NDA 050796 · B BRAUN MEDICAL INC · Prescription

Key facts

Proprietary name CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
Active ingredients CEFTRIAXONE SODIUM
Strength EQ 2GM BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application NDA050796
Applicant holder B BRAUN MEDICAL INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Apr 20, 2005

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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