Orange Book product

NICOTINE POLACRILEX EQ 2MG BASE

Orange Book ANDA 074507 · P AND L DEVELOPMENT LLC · Over the counter

Key facts

Proprietary name NICOTINE POLACRILEX
Active ingredients NICOTINE POLACRILEX
Strength EQ 2MG BASE
Dosage form GUM, CHEWING
Route BUCCAL
Application ANDA074507
Applicant holder P AND L DEVELOPMENT LLC
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 15, 1999

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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