Smoking Cessation

• FDA approval · 2022-01-05
  FDA Approved: CAREONE NICOTINE — Supplemental Application (American Sales Company)

  FDA granted a supplemental approval for CAREONE NICOTINE (nicotine polacrilex) by American Sales Company under ANDA206393.

• FDA approval · 2021-11-09
  FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NICORETTE (nicotine polacrilex), a nicotine replacement therapy, submitted by Haleon US Holdings…

• FDA approval · 2021-04-23
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC.

• FDA approval · 2020-12-21
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for bupropion hydrochloride by Aurobindo Pharma Limited.

• FDA approval · 2020-12-21
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Bupropion hydrochloride sustained-release by Slate Run Pharmaceuticals, LLC.

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• FDA approval · 2020-12-15
  FDA Approved: NICOTINE POLACRILEX — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA has approved a supplemental application for NICOTINE POLACRILEX from Dr. Reddy's Laboratories Inc.

• FDA approval · 2020-11-30
  FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic Bupropion hydrochloride under an original application.

• FDA approval · 2020-06-30
  FDA Approved: BUPROPION HYDROCHLORIDE (XL) — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for bupropion hydrochloride extended-release (XL) from Exelan Pharmaceuticals Inc., enabling continu…

• FDA approval · 2020-03-05
  FDA Approved: BUPROPION — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Bupropion by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2019-12-27
  FDA Approved: NICOTINE MINI — Supplemental Application (Walgreen Company)

  FDA approved a supplemental application for NICOTINE MINI (nicotine polacrilex), submitted by Walgreens, under ANDA203690.

• FDA approval · 2019-11-15
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approved a supplemental application to market NICORETTE 4MG Fruit Chill Gum by Lil' Drug Store Products, Inc., with nicotine polacrilex …

• FDA approval · 2019-11-01
  FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)

  FDA approved a supplemental application for Equate Nicotine (nicotine polacrilex) from Wal-Mart Stores Inc. This action updates the regulato…

• FDA approval · 2019-11-01
  FDA Approved: GOOD SENSE NICOTINE — Supplemental Application (L. Perrigo Company)

  FDA approves a supplemental application for Good Sense Nicotine (nicotine polacrilex) submitted by L. Perrigo Company to support continued m…

• FDA approval · 2019-02-22
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for CHANTIX (varenicline tartrate) from Pfizer. The action updates the drug's labeling.

• FDA approval · 2018-11-14
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  The FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM by Lil' Drug Store Products, confirming continued marketing of…

• FDA approval · 2018-11-14
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrylex) from Haleon US Holdings LLC.

• FDA approval · 2018-07-23
  FDA Approved: TOPCARE NICOTINE — Supplemental Application (Topco Associates LLC)

  The FDA approved a supplemental application for TOPCARE NICOTINE (nicotine polacrilex) from Topco Associates LLC.

• FDA approval · 2018-06-01
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Chantix (varenicline tartrate) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2017-12-11
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM from Lil' Drug Store Products, Inc. as a nicotine replacement prod…

• FDA approval · 2017-10-16
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for CHANTIX (varenicline tartrate) submitted by Pfizer Laboratories Div Pfizer Inc, resulting in…

• FDA approval · 2017-09-26
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for a generic Bupropion hydrochloride product from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2017-06-12
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Bupropion hydrochloride from Aurobindo Pharma Limited, granting generic drug status for this API…

• FDA approval · 2017-04-17
  FDA Approved: GOOD NEIGHBOR PHARMACY NICOTINE — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for GOOD NEIGHBOR PHARMACY NICOTINE (nicotine polacrilex), expanding its approval for this nicot…

• FDA approval · 2017-04-12
  FDA Approved: BUPROPION HYDROCHLORIDE (XL) — Original Application (ScieGen Pharmaceuticals,Inc.)

  FDA approved ScieGen Pharmaceuticals' generic bupropion hydrochloride extended-release (XL) for the same indications as the reference produc…

• FDA approval · 2016-12-16
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Chantix (varenicline tartrate) submitted by Pfizer Laboratories Div Pfizer Inc.