Drug application

GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)

Drugs@FDA ANDA 090663 · HAMELN RDS GMBH

Key facts

Drug name GEMCITABINE HYDROCHLORIDE
Active ingredients GEMCITABINE HYDROCHLORIDE
Application type ANDA
Application number 090663
Company HAMELN RDS GMBH
Dosage forms INJECTABLE, INJECTION
Strength EQ 200MG BASE/VIAL
Marketing status Discontinued
Reference listed drug No
Latest submission status date Sep 10, 2012

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None 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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