Drug application

SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)

Drugs@FDA ANDA 077397 · INVAGEN PHARMS

Key facts

Drug name SERTRALINE HYDROCHLORIDE
Active ingredients SERTRALINE HYDROCHLORIDE
Application type ANDA
Application number 077397
Company INVAGEN PHARMS
Dosage forms TABLET, ORAL
Strength EQ 25MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Feb 6, 2007

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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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