Orange Book product

OCUMYCIN 500 UNITS/GM;10,000 UNITS/GM

Orange Book ANDA 062430 · PHARMAFAIR INC · Discontinued

Key facts

Proprietary name OCUMYCIN
Active ingredients BACITRACIN ZINC, POLYMYXIN B SULFATE
Strength 500 UNITS/GM;10,000 UNITS/GM
Dosage form OINTMENT
Route OPHTHALMIC
Application ANDA062430
Applicant holder PHARMAFAIR INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 8, 1983

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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