Orange Book product

CALCITRIOL 1MCG/ML

Orange Book ANDA 203973 · ANDA REPOSITORY LLC · Prescription

Key facts

Proprietary name CALCITRIOL
Active ingredients CALCITRIOL
Strength 1MCG/ML
Dosage form SOLUTION
Route ORAL
Application ANDA203973
Applicant holder ANDA REPOSITORY LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 28, 2023

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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