Orange Book product

BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL

Orange Book ANDA 205030 · MEITHEAL PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name BLEOMYCIN SULFATE
Active ingredients BLEOMYCIN SULFATE
Strength EQ 30 UNITS BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA205030
Applicant holder MEITHEAL PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 20, 2018

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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