Drug application

GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)

Drugs@FDA ANDA 204549 · ACTAVIS INC

Key facts

Drug name GEMCITABINE HYDROCHLORIDE
Active ingredients GEMCITABINE HYDROCHLORIDE
Application type ANDA
Application number 204549
Company ACTAVIS INC
Dosage forms INJECTABLE, INJECTION
Strength 200MG/5.26ML (38MG/ML)
Marketing status Discontinued
Reference listed drug No
Latest submission status date Apr 11, 2016

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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