Orange Book product

DIAZEPAM 20MG/4ML (5MG/ML)

Orange Book ANDA 219882 · BAXTER HEALTHCARE CORP · Prescription

Key facts

Proprietary name DIAZEPAM
Active ingredients DIAZEPAM
Strength 20MG/4ML (5MG/ML)
Dosage form INJECTABLE
Route INJECTION
Application ANDA219882
Applicant holder BAXTER HEALTHCARE CORP
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jul 28, 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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