Orange Book product

METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML

Orange Book NDA 018890 · HOSPIRA INC · Prescription

Key facts

Proprietary name METRONIDAZOLE IN PLASTIC CONTAINER
Active ingredients METRONIDAZOLE
Strength 500MG/100ML
Dosage form INJECTABLE
Route INJECTION
Application NDA018890
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Nov 18, 1983

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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