Drug application

SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)

Drugs@FDA ANDA 078053 · RANBAXY LABS LTD

Key facts

Drug name SERTRALINE HYDROCHLORIDE
Active ingredients SERTRALINE HYDROCHLORIDE
Application type ANDA
Application number 078053
Company RANBAXY LABS LTD
Dosage forms CONCENTRATE, ORAL
Strength EQ 20MG BASE/ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Nov 30, 2006

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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