Orange Book product

LIDOCAINE 5%

Orange Book ANDA 200675 · ACTAVIS LABORATORIES UT INC · Prescription

Key facts

Proprietary name LIDOCAINE
Active ingredients LIDOCAINE
Strength 5%
Dosage form PATCH
Route TOPICAL
Application ANDA200675
Applicant holder ACTAVIS LABORATORIES UT INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 23, 2012

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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