Drug application

GRANISETRON HYDROCHLORIDE (GRANISETRON HYDROCHLORIDE)

Drugs@FDA ANDA 078522 · FRESENIUS KABI USA

Key facts

Drug name GRANISETRON HYDROCHLORIDE
Active ingredients GRANISETRON HYDROCHLORIDE
Application type ANDA
Application number 078522
Company FRESENIUS KABI USA
Dosage forms INJECTABLE, INJECTION
Strength EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Dec 31, 2007

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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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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