Orange Book product

MEDROXYPROGESTERONE ACETATE 10MG

Orange Book ANDA 040159 · BARR LABORATORIES INC · Prescription

Key facts

Proprietary name MEDROXYPROGESTERONE ACETATE
Active ingredients MEDROXYPROGESTERONE ACETATE
Strength 10MG
Dosage form TABLET
Route ORAL
Application ANDA040159
Applicant holder BARR LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 9, 1996

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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