Orange Book product

NORETHINDRONE AND ETHINYL ESTRADIOL 0.035MG;1MG

Orange Book ANDA 070685 · WATSON PHARMACEUTICALS INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name NORETHINDRONE AND ETHINYL ESTRADIOL
Active ingredients ETHINYL ESTRADIOL, NORETHINDRONE
Strength 0.035MG;1MG
Dosage form TABLET
Route ORAL-21
Application ANDA070685
Applicant holder WATSON PHARMACEUTICALS INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 29, 1987

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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