Orange Book product

PHYTONADIONE 1MG/0.5ML

Orange Book ANDA 215820 · DR REDDYS LABORATORIES LTD · Prescription

Key facts

Proprietary name PHYTONADIONE
Active ingredients PHYTONADIONE
Strength 1MG/0.5ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA215820
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 15, 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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