Orange Book product

DAPTOMYCIN 500MG/VIAL

Orange Book ANDA 212513 · BE PHARMACEUTICALS AG · Prescription

Key facts

Proprietary name DAPTOMYCIN
Active ingredients DAPTOMYCIN
Strength 500MG/VIAL
Dosage form POWDER
Route INTRAVENOUS
Application ANDA212513
Applicant holder BE PHARMACEUTICALS AG
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 26, 2019

At a glance

  • 10–99 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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