Nicotine Dependence

• FDA approval · 2007-05-24
  FDA Approved: FOSTER AND THRIVE NICOTINE — Original Application (Strategic Sourcing Services LLC)

  The FDA approved the original ANDA for Foster and Thrive Nicotine (nicotine polacrilex) from Strategic Sourcing Services LLC, a generic nico…

• FDA approval · 2007-05-01
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Bupropion hydrochloride from Aurobindo Pharma Limited, authorizing the generic product under an …

• FDA approval · 2007-03-08
  FDA Approved: NICOTINE POLACRILEX MINT — Supplemental Application (Walgreens)

  The FDA approved Walgreens' supplemental application for Nicotine Polacrilex Mint (nicotine polacrilex), expanding the approved nicotine rep…

• FDA approval · 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, expanding its labeling for this nicotine replace…

• FDA approval · 2006-12-08
  FDA Approved: NICOTINE POLACRILEX MINT — Supplemental Application (Walgreens)

  FDA approved a supplemental application for Nicotine Polacrilex Mint, adding a mint-flavored nicotine replacement therapy product from Walgr…

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• FDA approval · 2006-12-08
  FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Nicotine Polacrilex Gum Original Flavor, expanding the approved product to include this fl…

• FDA approval · 2006-12-08
  FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)

  FDA approves a supplemental application for Rugby Nicotine Polacrillex Gum Original Flavor, maintaining approval for this nicotine replaceme…

• FDA approval · 2006-10-30
  FDA Approved: NICOTINE — Original Application (H E B)

  FDA approved the original application for NICOTINE (nicotine polacrilex) gum from H E B, granting approval for this generic nicotine replace…

• FDA approval · 2006-10-30
  FDA Approved: EQUATE NICOTINE — Original Application (Wal-Mart Stores Inc)

  FDA approved Equate Nicotine under an Original Application (ANDA) by Wal-Mart Stores Inc for nicotine polacrilex gum, a generic nicotine rep…

• FDA approval · 2006-10-05
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York's supplemental application for a generic form of bupropion hydrochloride, authorizing it…

• FDA approval · 2006-09-15
  FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)

  FDA approved a supplemental application for the nicotine transdermal system (nicotine patch) filed by Sam's West Inc, updating the product's…

• FDA approval · 2006-06-13
  FDA Approved: DG HEALTH NICOTINE — Supplemental Application (Dolgencorp Inc)

  FDA approved a supplemental application for DG Health Nicotine (nicotine polacrylex) from Dolgencorp Inc under the ANDA. This action updates…

• FDA approval · 2006-06-13
  FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)

  FDA approved a supplemental application for Equate Nicotine (nicotine polacrilex gum), Walmart's store-brand nicotine replacement therapy. T…

• FDA approval · 2006-05-10
  FDA Approved: CHANTIX — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved CHANTIX (varenicline tartrate) as a smoking cessation aid under the Original Application (NDA).

• FDA approval · 2006-05-05
  FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Dr. Reddys Laboratories Inc.)

  FDA approved a supplemental application for the Nicotine Transdermal System (nicotine patch) from Dr. Reddys Laboratories Inc., maintaining/…

• FDA approval · 2006-05-04
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2006-05-04
  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 by Lil' Drug Store Products, Inc., enabling market authorization o…