Orange Book product

PENTOBARBITAL SODIUM 50MG/ML

Orange Book ANDA 206677 · BPI LABS LLC · Prescription

Key facts

Proprietary name PENTOBARBITAL SODIUM
Active ingredients PENTOBARBITAL SODIUM
Strength 50MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA206677
Applicant holder BPI LABS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 27, 2017

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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