Orange Book product

POLOCAINE W/ LEVONORDEFRIN 0.05MG/ML;2%

Orange Book ANDA 089517 · DENTSPLY PHARMACEUTICAL · Discontinued

Key facts

Proprietary name POLOCAINE W/ LEVONORDEFRIN
Active ingredients LEVONORDEFRIN, MEPIVACAINE HYDROCHLORIDE
Strength 0.05MG/ML;2%
Dosage form INJECTABLE
Route INJECTION
Application ANDA089517
Applicant holder DENTSPLY PHARMACEUTICAL
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 14, 1988

At a glance

  • None 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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