Orange Book product

NORETHINDRONE AND ETHINYL ESTRADIOL 0.035MG;0.5MG

Orange Book ANDA 070686 · DR REDDYS LABORATORIES SA · Discontinued

Key facts

Proprietary name NORETHINDRONE AND ETHINYL ESTRADIOL
Active ingredients ETHINYL ESTRADIOL, NORETHINDRONE
Strength 0.035MG;0.5MG
Dosage form TABLET
Route ORAL-28
Application ANDA070686
Applicant holder DR REDDYS LABORATORIES SA
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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