Orange Book product

LIDOCAINE HYDROCHLORIDE 2%

Orange Book ANDA 218676 · QUAGEN PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name LIDOCAINE HYDROCHLORIDE
Active ingredients LIDOCAINE HYDROCHLORIDE
Strength 2%
Dosage form SOLUTION
Route ORAL
Application ANDA218676
Applicant holder QUAGEN PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 20, 2026

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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