Orange Book product

BRETYLIUM TOSYLATE 50MG/ML

Orange Book ANDA 070545 · HIKMA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name BRETYLIUM TOSYLATE
Active ingredients BRETYLIUM TOSYLATE
Strength 50MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA070545
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 14, 1986

At a glance

  • None 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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