Drug application

AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM, SULBACTAM SODIUM)

Drugs@FDA ANDA 065074 · HIKMA PHARMS

Key facts

Drug name AMPICILLIN AND SULBACTAM
Active ingredients AMPICILLIN SODIUM, SULBACTAM SODIUM
Application type ANDA
Application number 065074
Company HIKMA PHARMS
Dosage forms INJECTABLE, INJECTION
Strength EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Marketing status Discontinued
TE codes AP
Reference listed drug No
Latest submission status date Mar 19, 2002

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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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