Orange Book product

CYTARABINE 100MG/VIAL

Orange Book ANDA 211937 · GLAND PHARMA LTD · Prescription

Key facts

Proprietary name CYTARABINE
Active ingredients CYTARABINE
Strength 100MG/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA211937
Applicant holder GLAND PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 23, 2019

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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