Orange Book product

SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that…

Orange Book NDA 019667 · NOVARTIS PHARMACEUTICALS CORP · Discontinued

Key facts

Proprietary name SANDOSTATIN
Active ingredients OCTREOTIDE ACETATE
Strength EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form INJECTABLE
Route INJECTION
Application NDA019667
Applicant holder NOVARTIS PHARMACEUTICALS CORP
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jun 12, 1991

At a glance

  • None 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)

Browse all Orange Book products