Orange Book product

OCTREOTIDE ACETATE EQ 0.2MG BASE/ML

Orange Book ANDA 076330 · WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD · Prescription

Key facts

Proprietary name OCTREOTIDE ACETATE
Active ingredients OCTREOTIDE ACETATE
Strength EQ 0.2MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA076330
Applicant holder WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 8, 2005

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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