Orange Book product

LEVONORGESTREL AND ETHINYL ESTRADIOL 0.03MG;0.15MG

Orange Book ANDA 207033 · NAARI PTE LTD · Prescription

Key facts

Proprietary name LEVONORGESTREL AND ETHINYL ESTRADIOL
Active ingredients ETHINYL ESTRADIOL, LEVONORGESTREL
Strength 0.03MG;0.15MG
Dosage form TABLET
Route ORAL-28
Application ANDA207033
Applicant holder NAARI PTE LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 9, 2020

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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