Orange Book product

DIPYRIDAMOLE 5MG/ML

Orange Book ANDA 074939 · CHARTWELL INJECTABLES LLC · Prescription

Key facts

Proprietary name DIPYRIDAMOLE
Active ingredients DIPYRIDAMOLE
Strength 5MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA074939
Applicant holder CHARTWELL INJECTABLES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 13, 1998

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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