Orange Book product

BUMETANIDE 2MG

Orange Book ANDA 213458 · TARO PHARMACEUTICAL INDUSTRIES LTD · Prescription

Key facts

Proprietary name BUMETANIDE
Active ingredients BUMETANIDE
Strength 2MG
Dosage form TABLET
Route ORAL
Application ANDA213458
Applicant holder TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 24, 2023

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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