Orange Book product

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) 500MG;500MG;30MG

Orange Book ANDA 200218 · ANI PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
Active ingredients AMOXICILLIN, CLARITHROMYCIN, LANSOPRAZOLE
Strength 500MG;500MG;30MG
Dosage form CAPSULE, TABLET, DELAYED REL PELLETS
Route ORAL
Application ANDA200218
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 30, 2013

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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