Orange Book product

PROCAN SR 500MG

Orange Book ANDA 086065 · PARKEDALE PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name PROCAN SR
Active ingredients PROCAINAMIDE HYDROCHLORIDE
Strength 500MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA086065
Applicant holder PARKEDALE PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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