Drug application

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX)

Drugs@FDA ANDA 078215 · HIKMA PHARMS

Key facts

Drug name SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
Active ingredients SODIUM FERRIC GLUCONATE COMPLEX
Application type ANDA
Application number 078215
Company HIKMA PHARMS
Dosage forms INJECTABLE, INJECTION
Strength EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 31, 2011

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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