Orange Book product

CIPROFLOXACIN 250MG/5ML

Orange Book ANDA 200563 · CHARTWELL LIFE MOLECULES LLC · Prescription

Key facts

Proprietary name CIPROFLOXACIN
Active ingredients CIPROFLOXACIN
Strength 250MG/5ML
Dosage form FOR SUSPENSION
Route ORAL
Application ANDA200563
Applicant holder CHARTWELL LIFE MOLECULES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 5, 2014

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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