Nicotine Dependence
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FDA approval · 2013-01-28FDA Approved: NICOTINE — Supplemental Application (P & L Development, LLC)
FDA approved a supplemental application for NICOTINE (nicotine polacrilex) submitted by P & L Development, LLC under ANDA079044. This indica…
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FDA approval · 2013-01-28FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)
FDA approved a supplemental application for Rugby Nicotine Polacrilex Gum, Original Flavor, a nicotine replacement therapy intended to aid s…
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FDA approval · 2013-01-28FDA Approved: NICOTINE — Supplemental Application (P & L Development, LLC)
The FDA approved a supplemental application for nicotine polacrilex (nicotine) by P & L Development, LLC under ANDA079038, supporting its us…
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FDA approval · 2012-11-29FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)
The FDA approved a supplemental application for Equate Nicotine gum (nicotine polacrilex) from Wal-Mart Stores Inc., confirming market autho…
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FDA approval · 2012-11-29FDA Approved: DG HEALTH NICOTINE — Supplemental Application (Dolgencorp Inc)
FDA approved a supplemental application for DG HEALTH NICOTINE (nicotine polacrilex) from Dolgencorp Inc.
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FDA approval · 2012-11-29FDA Approved: NICOTINE — Supplemental Application (H E B)
FDA approved a supplemental application for NICOTINE products (NICOTINE and NICOTINE POLACRILEX) from H E B under an ANDA.
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FDA approval · 2012-11-29FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)
The FDA approved a supplemental application for Equate Nicotine (nicotine polacrilex gum) submitted by Wal-Mart Stores Inc under an existing…
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FDA approval · 2012-11-29FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)
FDA approved a supplemental application for EQUATE NICOTINE (nicotine polacrilex) from Wal-Mart Stores Inc.
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FDA approval · 2012-11-29FDA Approved: GOOD NEIGHBOR PHARMACY NICOTINE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy Nicotine (nicotine polacrilex) from AmerisourceBergen.
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FDA approval · 2012-11-29FDA Approved: BASIC CARE NICOTINE — Supplemental Application (Amazon.com Services LLC)
FDA approves a supplemental application for BASIC CARE NICOTINE (nicotine polacrilex) submitted by Amazon.com Services LLC.
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FDA approval · 2012-11-29FDA Approved: GOOD SENSE NICOTINE — Supplemental Application (L. Perrigo Company)
FDA approved a supplemental application for Good Sense Nicotine (nicotine polacrilex) by L. Perrigo Company. The product is a nicotine gum i…
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FDA approval · 2012-10-09FDA Approved: NICOTINE MINI — Original Application (Walgreen Company)
FDA approves Walgreen Company's NICOTINE MINI (nicotine polacrilex) as an original ANDA, adding a generic nicotine replacement lozenge to th…
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FDA approval · 2012-09-28FDA Approved: QUITINE NICOTINE — Supplemental Application (QUITINE LLC)
FDA approved a supplemental application for QUITINE NICOTINE (nicotine polacrilex) from Quitine LLC.
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FDA approval · 2012-09-28FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)
FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrilex) from Strategic Sourcing Services LLC.
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FDA approval · 2012-09-20FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)
The FDA approved a supplemental application for the Nicotine Transdermal System (nicotine patch) submitted by Sam's West Inc. The approval u…
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FDA approval · 2012-09-18FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for Nicorette (nicotine polacrilex) by Haleon US Holdings LLC. The approval updates the product's re…
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FDA approval · 2012-08-01FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for Nicorette 4 mg Fruit Chill Gum marketed by Lil' Drug Store Products, confirming authorization fo…
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FDA approval · 2012-08-01FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC.
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FDA approval · 2012-07-16FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
The FDA approved a supplemental application for Nicorette 4 mg Fruit Chill Gum from Lil’ Drug Store Products, Inc., allowing continued marke…
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FDA approval · 2012-07-16FDA 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 approval indicates reg…
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FDA approval · 2012-05-23FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
The FDA approved a supplemental application for NICORETTE (nicotine polacrilex) from Haleon US Holdings LLC.
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FDA approval · 2012-04-25FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)
FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrilex) submitted by Strategic Sourcing Services LLC.
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FDA approval · 2012-04-23FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Actavis Pharma, Inc.)
FDA approves a supplemental application for Bupropion HCl sustained-release (Actavis), finalizing changes to the approved generic product.
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FDA approval · 2012-04-19FDA Approved: BASIC CARE NICOTINE — Supplemental Application (Amazon.com Services LLC)
The FDA approved a supplemental application for Basic Care Nicotine (nicotine polacrillex) from Amazon.com Services LLC, updating its regula…
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FDA approval · 2012-04-18FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bupropion Hydrochloride SR from Actavis Pharma, Inc.