Orange Book product

CEFAZOLIN SODIUM EQ 10GM BASE/VIAL

Orange Book ANDA 065143 · HIKMA FARMACEUTICA PORTUGAL LDA · Prescription

Key facts

Proprietary name CEFAZOLIN SODIUM
Active ingredients CEFAZOLIN SODIUM
Strength EQ 10GM BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA065143
Applicant holder HIKMA FARMACEUTICA PORTUGAL LDA
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 18, 2004

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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