Orange Book product

DIPRIVAN 10MG/ML

Orange Book NDA 019627 · FRESENIUS KABI USA LLC · Prescription

Key facts

Proprietary name DIPRIVAN
Active ingredients PROPOFOL
Strength 10MG/ML
Dosage form INJECTABLE
Route INJECTION
Application NDA019627
Applicant holder FRESENIUS KABI USA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jun 11, 1996

At a glance

  • 10–99 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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