Orange Book product

LUBIPROSTONE 24MCG

Orange Book ANDA 218640 · ASCENT PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name LUBIPROSTONE
Active ingredients LUBIPROSTONE
Strength 24MCG
Dosage form CAPSULE
Route ORAL
Application ANDA218640
Applicant holder ASCENT PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 2, 2025

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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