Orange Book product

VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE

Orange Book NDA 022104 · OSMOTICA PHARMACEUTICAL US LLC · Prescription

Key facts

Proprietary name VENLAFAXINE HYDROCHLORIDE
Active ingredients VENLAFAXINE HYDROCHLORIDE
Strength EQ 225MG BASE
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application NDA022104
Applicant holder OSMOTICA PHARMACEUTICAL US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date May 20, 2008

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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