Orange Book product

MIRTAZAPINE 45MG

Orange Book ANDA 077959 · ACTAVIS ELIZABETH LLC · Discontinued

Key facts

Proprietary name MIRTAZAPINE
Active ingredients MIRTAZAPINE
Strength 45MG
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Application ANDA077959
Applicant holder ACTAVIS ELIZABETH LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 14, 2011

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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