Orange Book product

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML)

Orange Book ANDA 077909 · WOODWARD PHARMA SERVICES LLC · Prescription

Key facts

Proprietary name FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Active ingredients FLUCONAZOLE
Strength 200MG/100ML (2MG/ML)
Dosage form INJECTABLE
Route INJECTION
Application ANDA077909
Applicant holder WOODWARD PHARMA SERVICES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 26, 2010

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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