Orange Book product

NITROGLYCERIN 2%

Orange Book ANDA 087355 · FOUGERA PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name NITROGLYCERIN
Active ingredients NITROGLYCERIN
Strength 2%
Dosage form OINTMENT
Route TRANSDERMAL
Application ANDA087355
Applicant holder FOUGERA PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jul 8, 1988

At a glance

  • 1–9 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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