Orange Book product

ISOSORBIDE DINITRATE 40MG

Orange Book ANDA 040723 · IMPAX LABORATORIES INC · Discontinued

Key facts

Proprietary name ISOSORBIDE DINITRATE
Active ingredients ISOSORBIDE DINITRATE
Strength 40MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA040723
Applicant holder IMPAX LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 17, 2008

At a glance

  • None 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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