Orange Book product

BACITRACIN ZINC-POLYMYXIN B SULFATE 500 UNITS/GM;10,000 UNITS/GM

Orange Book ANDA 062849 · NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS · Discontinued

Key facts

Proprietary name BACITRACIN ZINC-POLYMYXIN B SULFATE
Active ingredients BACITRACIN ZINC, POLYMYXIN B SULFATE
Strength 500 UNITS/GM;10,000 UNITS/GM
Dosage form OINTMENT
Route TOPICAL
Application ANDA062849
Applicant holder NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 13, 1987

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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