Orange Book product

CEFOXITIN EQ 10GM BASE/VIAL

Orange Book ANDA 065239 · HIKMA FARMACEUTICA (PORTUGAL) SA · Prescription

Key facts

Proprietary name CEFOXITIN
Active ingredients CEFOXITIN SODIUM
Strength EQ 10GM BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA065239
Applicant holder HIKMA FARMACEUTICA (PORTUGAL) SA
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 2, 2010

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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