Orange Book product

FALLBACK SOLO 1.5MG

Orange Book ANDA 201446 · LUPIN LTD · Over the counter

Key facts

Proprietary name FALLBACK SOLO
Active ingredients LEVONORGESTREL
Strength 1.5MG
Dosage form TABLET
Route ORAL
Application ANDA201446
Applicant holder LUPIN LTD
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 19, 2014

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)

Browse all Orange Book products