Nicotine Dependence

• FDA approval · 2012-03-28
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)

  FDA approved a supplemental application for Bupropion Hydrochloride from Apnar Pharma LP, confirming approval of a generic formulation.

• FDA approval · 2012-02-21
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application for bupropion hydrochloride (generic), confirming approval fo…

• FDA approval · 2012-02-15
  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 (nicotine polacrilex) from Lil' Drug Store Products, expanding nic…

• FDA approval · 2012-02-15
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2012-02-01
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  The FDA approved a supplemental application to allow Lil' Drug Store Products, Inc. to market Nicorette 4 mg Fruit Chill Gum (nicotine polac…

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• FDA approval · 2012-02-01
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2012-01-20
  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. The approval…

• FDA approval · 2011-12-15
  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, confirming it as an appr…

• FDA approval · 2011-12-06
  FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Nicorette (nicotine polacrilex) from Haleon US Holdings LLC.

• FDA approval · 2011-11-10
  FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved bupropion hydrochloride from Upsher-Smith Laboratories in an original application, authorizing its use for major depressive dis…

• FDA approval · 2011-11-09
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

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

• FDA approval · 2011-10-31
  FDA Approved: DG HEALTH NICOTINE — Supplemental Application (Dolgencorp Inc)

  FDA approves a supplemental application for DG Health Nicotine (nicotine polacrilex) by Dolgencorp Inc, a nicotine replacement therapy indic…

• FDA approval · 2011-09-27
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex gum) submitted by Haleon US Holdings LLC.

• FDA approval · 2011-09-27
  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 from Lil' Drug Store Products, Inc., confirming continued regu…

• FDA approval · 2011-09-12
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC. The action relates to nico…

• FDA approval · 2011-08-30
  FDA Approved: GOOD SENSE NICOTINE — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for Good Sense Nicotine (nicotine polacrilex) by Perrigo Company under ANDA 076775.

• FDA approval · 2011-08-30
  FDA Approved: GOOD NEIGHBOR PHARMACY NICOTINE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Nicotine (nicotine polacrylex) submitted by AmerisourceBergen. The produc…

• FDA approval · 2011-08-08
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for bupropion hydrochloride from Aurobindo Pharma Limited, allowing the generic product to be market…

• FDA approval · 2011-07-20
  FDA Approved: BASIC CARE NICOTINE — Original Application (Amazon.com Services LLC)

  FDA approved Basic Care Nicotine (nicotine polacrilex) under an Original Application (ANDA) from Amazon.com Services LLC, adding a store-bra…

• FDA approval · 2011-05-17
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2011-05-17
  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. (nicotine polacrilex) for …

• FDA approval · 2011-02-17
  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, updating the…

• FDA approval · 2011-01-21
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for bupropion hydrochloride from BluePoint Laboratories, approving changes to an existing generic pr…

• FDA approval · 2010-12-17
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved Pfizer's supplemental application for CHANTIX (varenicline tartrate).

• FDA approval · 2010-08-30
  FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Bupropion Hydrochloride XL (Actavis), a generic extended-release formulation of bupropion hydroc…