Orange Book product

NITROLINGUAL PUMPSPRAY 0.4MG/SPRAY

Orange Book NDA 018705 · POHL BOSKAMP · Prescription

Key facts

Proprietary name NITROLINGUAL PUMPSPRAY
Active ingredients NITROGLYCERIN
Strength 0.4MG/SPRAY
Dosage form SPRAY, METERED
Route SUBLINGUAL
Application NDA018705
Applicant holder POHL BOSKAMP
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 10, 1997

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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