Orange Book product

OXANDROLONE 10MG

Orange Book ANDA 077827 · PAR PHARMACEUTICAL INC · Discontinued

Key facts

Proprietary name OXANDROLONE
Active ingredients OXANDROLONE
Strength 10MG
Dosage form TABLET
Route ORAL
Application ANDA077827
Applicant holder PAR PHARMACEUTICAL INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 22, 2007

At a glance

  • None 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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