Nicotine Dependence

• FDA approval · 2024-10-01
  FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Oryza pharmaceuticals Inc.)

  FDA approved a supplemental application for BUPROPION HYDROCHLORIDE XL from Oryza Pharmaceuticals Inc., indicating regulatory clearance of t…

• FDA approval · 2024-09-06
  FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2024-08-26
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Bupropion Hydrochloride from Sun Pharmaceutical Industries, Inc., confirming a generic version o…

• FDA approval · 2024-07-23
  FDA Approved: VARENICLINE — Original Application (Nivagen Pharmaceuticals Inc.)

  FDA approved the generic varenicline product from Nivagen Pharmaceuticals Inc. under an Original Application (ANDA 217115) for smoking cessa…

• FDA approval · 2024-07-12
  FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)

  The FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrylex) from Strategic Sourcing Services LLC, confi…

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• FDA approval · 2024-07-11
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals’ generic Bupropion hydrochloride under an ANDA, authorizing a modificatio…

• FDA approval · 2024-04-30
  FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2024-03-15
  FDA Approved: QUITINE NICOTINE — Supplemental Application (QUITINE LLC)

  FDA approved a supplemental application for QUITINE NICOTINE (nicotine polacrilex) from QUITINE LLC.

• FDA approval · 2024-03-15
  FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)

  The FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrilex) submitted by Strategic Sourcing Services LL…

• FDA approval · 2024-03-15
  FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)

  The FDA approved a supplemental application for EQUATE NICOTINE (nicotine polacrilex) submitted by Wal-Mart Stores Inc.

• FDA approval · 2024-03-15
  FDA Approved: GOOD NEIGHBOR PHARMACY NICOTINE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Nicotine (nicotine polacrilex) under ANDA076789, representing an approved…

• FDA approval · 2024-03-15
  FDA Approved: BASIC CARE NICOTINE — Supplemental Application (Amazon.com Services LLC)

  FDA approved a supplemental application for BASIC CARE NICOTINE (nicotine polacrilex) submitted by Amazon.com Services LLC.

• FDA approval · 2024-03-15
  FDA Approved: NICOTINE — Supplemental Application (H E B)

  FDA approves a supplemental application for NICOTINE (nicotine polacrilex) from H E B, indicating an updated label or additional use for thi…

• FDA approval · 2024-03-15
  FDA Approved: GOOD SENSE NICOTINE — Supplemental Application (L. Perrigo Company)

  The FDA approved a supplemental application for Good Sense Nicotine (nicotine polacrilex) by L. Perrigo Company. This action confirms an upd…

• FDA approval · 2024-02-29
  FDA Approved: VARENICLINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original application for a generic varenicline product for smoking cessation, manufactured by Mylan Pharmaceuticals Inc.

• FDA approval · 2024-01-23
  FDA Approved: VARENICLINE — Supplemental Application (ENDO USA, Inc.)

  The FDA approved a supplemental application for varenicline tartrate from ENDO USA, Inc., related to the varenicline product.

• FDA approval · 2024-01-03
  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. This action represents reg…

• FDA approval · 2024-01-03
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approves a supplemental application for Nicorette 4 mg Fruit Chill gum (nicotine polacrilex) from Lil' Drug Store Products, Inc.

• FDA approval · 2023-12-04
  FDA Approved: VARENICLINE TARTRATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic varenicline tartrate for smoking cessation via an Original Application (ANDA).

• FDA approval · 2023-09-21
  FDA Approved: AMAZON BASIC CARE NICOTINE POLACRILEX — Supplemental Application (Amazon.com Services LLC)

  The FDA approved a supplemental application for Amazon Basic Care Nicotine Polacrilex, confirming it as an over-the-counter nicotine replace…

• FDA approval · 2023-09-21
  FDA Approved: TOPCARE NICOTINE — Supplemental Application (Topco Associates LLC)

  FDA supplemental approval for Topcare Nicotine (nicotine polacrilex) under an ANDA filed by Topco Associates LLC.

• FDA approval · 2023-08-02
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental ANDA for a generic formulation of bupropion hydrochloride by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2023-08-01
  FDA Approved: VARENICLINE TARTRATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original abbreviated new drug application for Varenicline Tartrate from Glenmark, a generic version of varenicline tartrate…

• FDA approval · 2023-07-25
  FDA Approved: VARENICLINE TARTRATE — Original Application (Leading Pharma, LLC)

  The FDA approved the original Abbreviated New Drug Application for varenicline tartrate from Leading Pharma, LLC, enabling a generic version…

• FDA approval · 2023-06-12
  FDA Approved: VARENICLINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original ANDA for varenicline from Zydus Lifesciences Limited, a generic product indicated for smoking cessation in adults.