Orange Book product

NICOTINE POLACRILEX EQ 2MG BASE

Orange Book ANDA 076775 · L PERRIGO CO · Over the counter

Key facts

Proprietary name NICOTINE POLACRILEX
Active ingredients NICOTINE POLACRILEX
Strength EQ 2MG BASE
Dosage form GUM, CHEWING
Route BUCCAL
Application ANDA076775
Applicant holder L PERRIGO CO
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 16, 2004

At a glance

  • 10–99 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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