Orange Book product

PERPHENAZINE 8MG **Federal Register determination that product was not…

Orange Book ANDA 089456 · ANI PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name PERPHENAZINE
Active ingredients PERPHENAZINE
Strength 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form TABLET
Route ORAL
Application ANDA089456
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 10, 1987

At a glance

  • None 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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