Orange Book product

CLOPIDOGREL BISULFATE EQ 75MG BASE

Orange Book ANDA 203632 · ALKEM LABORATORIES LTD · Prescription

Key facts

Proprietary name CLOPIDOGREL BISULFATE
Active ingredients CLOPIDOGREL BISULFATE
Strength EQ 75MG BASE
Dosage form TABLET
Route ORAL
Application ANDA203632
Applicant holder ALKEM LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 8, 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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