Orange Book product

LIDOCAINE HYDROCHLORIDE 2%

Orange Book ANDA 216780 · RUBICON RESEARCH LTD · Prescription

Key facts

Proprietary name LIDOCAINE HYDROCHLORIDE
Active ingredients LIDOCAINE HYDROCHLORIDE
Strength 2%
Dosage form SOLUTION
Route ORAL
Application ANDA216780
Applicant holder RUBICON RESEARCH LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Mar 28, 2023

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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