Orange Book product

MUPIROCIN 2%

Orange Book ANDA 065123 · PADAGIS ISRAEL PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name MUPIROCIN
Active ingredients MUPIROCIN
Strength 2%
Dosage form OINTMENT
Route TOPICAL
Application ANDA065123
Applicant holder PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Nov 7, 2003

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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