Orange Book product

PEMETREXED DISODIUM EQ 1GM BASE/VIAL

Orange Book ANDA 090384 · FRESENIUS KABI USA LLC · Prescription

Key facts

Proprietary name PEMETREXED DISODIUM
Active ingredients PEMETREXED DISODIUM
Strength EQ 1GM BASE/VIAL
Dosage form POWDER
Route INTRAVENOUS
Application ANDA090384
Applicant holder FRESENIUS KABI USA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 25, 2022

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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