Orange Book product

NORTREL 0.5/35-21 0.035MG;0.5MG

Orange Book ANDA 072692 · BARR LABORATORIES INC · Discontinued

Key facts

Proprietary name NORTREL 0.5/35-21
Active ingredients ETHINYL ESTRADIOL, NORETHINDRONE
Strength 0.035MG;0.5MG
Dosage form TABLET
Route ORAL-21
Application ANDA072692
Applicant holder BARR LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 28, 1992

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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