Orange Book product

QUINIDINE SULFATE 300MG

Orange Book ANDA 088072 · EPIC PHARMA LLC · Prescription

Key facts

Proprietary name QUINIDINE SULFATE
Active ingredients QUINIDINE SULFATE
Strength 300MG
Dosage form TABLET
Route ORAL
Application ANDA088072
Applicant holder EPIC PHARMA LLC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Sep 26, 1983

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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