Orange Book product

VELIVET 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG

Orange Book ANDA 076455 · DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC · Prescription

Key facts

Proprietary name VELIVET
Active ingredients DESOGESTREL, ETHINYL ESTRADIOL
Strength 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
Dosage form TABLET
Route ORAL-28
Application ANDA076455
Applicant holder DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 24, 2004

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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