Orange Book product

LIDOCAINE HYDROCHLORIDE 1%

Orange Book ANDA 215132 · AFAXYS PHARMA LLC · Prescription

Key facts

Proprietary name LIDOCAINE HYDROCHLORIDE
Active ingredients LIDOCAINE HYDROCHLORIDE
Strength 1%
Dosage form INJECTABLE
Route INJECTION
Application ANDA215132
Applicant holder AFAXYS PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 9, 2022

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)

Browse all Orange Book products