Orange Book product

LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML)

Orange Book ANDA 091644 · RISING PHARMA HOLDINGS INC · Prescription

Key facts

Proprietary name LEVOFLOXACIN
Active ingredients LEVOFLOXACIN
Strength EQ 750MG/30ML (EQ 25MG/ML)
Dosage form INJECTABLE
Route INJECTION
Application ANDA091644
Applicant holder RISING PHARMA HOLDINGS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jun 20, 2011

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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