Orange Book product

NITROGLYCERIN 5MG/ML

Orange Book ANDA 072034 · AMERICAN REGENT INC · Prescription

Key facts

Proprietary name NITROGLYCERIN
Active ingredients NITROGLYCERIN
Strength 5MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA072034
Applicant holder AMERICAN REGENT INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 24, 1988

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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