Orange Book product

FAMOTIDINE PRESERVATIVE FREE 10MG/ML

Orange Book ANDA 075789 · HIKMA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name FAMOTIDINE PRESERVATIVE FREE
Active ingredients FAMOTIDINE
Strength 10MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA075789
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 30, 2002

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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