Orange Book product

HYDROXYCHLOROQUINE SULFATE 400MG

Orange Book ANDA 213342 · ACCORD HEALTHCARE INC · Prescription

Key facts

Proprietary name HYDROXYCHLOROQUINE SULFATE
Active ingredients HYDROXYCHLOROQUINE SULFATE
Strength 400MG
Dosage form TABLET
Route ORAL
Application ANDA213342
Applicant holder ACCORD HEALTHCARE INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Aug 18, 2021

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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