Orange Book product

PODOFILOX 0.5%

Orange Book ANDA 075600 · PADAGIS US LLC · Prescription

Key facts

Proprietary name PODOFILOX
Active ingredients PODOFILOX
Strength 0.5%
Dosage form SOLUTION
Route TOPICAL
Application ANDA075600
Applicant holder PADAGIS US LLC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 29, 2002

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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