Orange Book product

WARFARIN SODIUM 3MG

Orange Book ANDA 090935 · INVAGEN PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name WARFARIN SODIUM
Active ingredients WARFARIN SODIUM
Strength 3MG
Dosage form TABLET
Route ORAL
Application ANDA090935
Applicant holder INVAGEN PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 25, 2011

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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