Orange Book product

CALCITONIN-SALMON 200 IU/ML

Orange Book ANDA 215864 · ZYDUS PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name CALCITONIN-SALMON
Active ingredients CALCITONIN SALMON
Strength 200 IU/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA215864
Applicant holder ZYDUS PHARMACEUTICALS USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 4, 2026

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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