Orange Book product

LANABIOTIC 400 UNITS/GM;40MG/GM;EQ 5MG BASE/GM;5,000 UNITS/GM

Orange Book ANDA 062499 · COMBE INC · Discontinued

Key facts

Proprietary name LANABIOTIC
Active ingredients BACITRACIN ZINC, LIDOCAINE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Strength 400 UNITS/GM;40MG/GM;EQ 5MG BASE/GM;5,000 UNITS/GM
Dosage form OINTMENT
Route TOPICAL
Application ANDA062499
Applicant holder COMBE INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 3, 1985

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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