Drug application

GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)

Drugs@FDA ANDA 202997 · DR REDDYS LABS LTD

Key facts

Drug name GEMCITABINE HYDROCHLORIDE
Active ingredients GEMCITABINE HYDROCHLORIDE
Application type ANDA
Application number 202997
Company DR REDDYS LABS LTD
Dosage forms INJECTABLE, INJECTION
Strength EQ 2GM BASE/VIAL
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date May 7, 2013

At a glance

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