Drug application

WELLBUTRIN XL (BUPROPION HYDROCHLORIDE)

Drugs@FDA NDA 021515 · BAUSCH

Key facts

Drug name WELLBUTRIN XL
Active ingredients BUPROPION HYDROCHLORIDE
Application type NDA
Application number 021515
Company BAUSCH
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 150MG
Marketing status Prescription
TE codes AB3
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Aug 28, 2003

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 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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