Orange Book product

VITAMIN K1 10MG/ML

Orange Book ANDA 087955 · HOSPIRA INC · Prescription

Key facts

Proprietary name VITAMIN K1
Active ingredients PHYTONADIONE
Strength 10MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA087955
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jul 25, 1983

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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