Orange Book product

LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG

Orange Book ANDA 077681 · DR REDDYS LABORATORIES SA · Prescription

Key facts

Proprietary name LEVONORGESTREL AND ETHINYL ESTRADIOL
Active ingredients ETHINYL ESTRADIOL, LEVONORGESTREL
Strength 0.02MG;0.1MG
Dosage form TABLET
Route ORAL-28
Application ANDA077681
Applicant holder DR REDDYS LABORATORIES SA
Marketing status Prescription
Therapeutic equivalence (TE) code AB2
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 31, 2006

At a glance

  • 10–99 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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