Drug application

CEFEPIME IN PLASTIC CONTAINER (CEFEPIME HYDROCHLORIDE)

Drugs@FDA NDA 050817 · BAXTER HLTHCARE

Key facts

Drug name CEFEPIME IN PLASTIC CONTAINER
Active ingredients CEFEPIME HYDROCHLORIDE
Application type NDA
Application number 050817
Company BAXTER HLTHCARE
Dosage forms INJECTABLE, INJECTION
Strength EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Aug 5, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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