Drug application

SILENOR (DOXEPIN HYDROCHLORIDE)

Drugs@FDA NDA 022036 · CURRAX

Key facts

Drug name SILENOR
Active ingredients DOXEPIN HYDROCHLORIDE
Application type NDA
Application number 022036
Company CURRAX
Dosage forms TABLET, ORAL
Strength EQ 3MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Mar 17, 2010

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 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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