Drug application

VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)

Drugs@FDA NDA 022104 · OSMOTICA PHARM US

Key facts

Drug name VENLAFAXINE HYDROCHLORIDE
Active ingredients VENLAFAXINE HYDROCHLORIDE
Application type NDA
Application number 022104
Company OSMOTICA PHARM US
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 37.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date May 20, 2008

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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 · Source date:

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