Nicotine Dependence

• FDA label_change · 2023-10-10
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)

  The FDA approved a supplemental application for bupropion hydrochloride from Apnar Pharma LP, indicating an approved change to an existing p…

• FDA label_change · 2017-04-14
  FDA Approved: RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application to add a coated mint flavor to Rugby Nicotine Polacrilex Gum, a nicotine replacement therapy for aid…

• FDA label_change · 2016-04-08
  FDA Approved: BASIC CARE NICOTINE — Supplemental Application (Amazon.com Services LLC)

  FDA approved a supplemental application for Basic Care Nicotine (nicotine polacrilex) from Amazon.com Services LLC, indicating a labeling-re…

• FDA label_change · 2014-09-19
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA supplemental application for CHANTIX (varenicline tartrate) submitted by Pfizer to modify the labeling.

• FDA label_change · 2007-08-02
  FDA Approved: WELLBUTRIN XL — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for WELLBUTRIN XL, resulting in changes to the product labeling.

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• FDA label_change · 2007-03-08
  FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Nicotine Polacrilex Gum Original Flavor to expand labeling with the Original Flavor under …