Drug application

PALONOSETRON HYDROCHLORIDE (PALONOSETRON HYDROCHLORIDE)

Drugs@FDA ANDA 204289 · SAGENT PHARMS INC

Key facts

Drug name PALONOSETRON HYDROCHLORIDE
Active ingredients PALONOSETRON HYDROCHLORIDE
Application type ANDA
Application number 204289
Company SAGENT PHARMS INC
Dosage forms INJECTABLE, INTRAVENOUS
Strength EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Sep 19, 2018

At a glance

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

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

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