Tobacco Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-11-05FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Bupropion hydrochloride from Aurobindo Pharma Limited, approving a new generic form of the antid…
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FDA approval · 2025-11-05FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for Bupropion Hydrochloride from BluePoint Laboratories. This action updates the approved generi…
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FDA approval · 2025-10-29FDA Approved: VARENICLINE TARTRATE — Original Application (Micro Labs Limited)
FDA approved the original ANDA for Varenicline tartrate from Micro Labs Limited. This approval confirms Micro Labs Limited's generic product…
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FDA approval · 2025-10-01FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original-application for generic bupropion hydrochloride, authorizing a new generic entry of the antide…
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EMA approval · 2025-09-11EMA Authorised: Champix (varenicline) — Pfizer Europe MA EEIG
The EMA authorised Champix (varenicline) for tobacco use cessation in the European Union, with Pfizer Europe MA EEIG as the marketing author…
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FDA approval · 2025-07-03FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Bupropion Hydrochloride XL, adding an extended-release formulation of bupro…
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FDA approval · 2025-04-18FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Dr. Reddys Laboratories Inc.)
FDA approved a supplemental application for Bupropion Hydrochloride SR from Dr. Reddy's Laboratories, authorizing its continued marketing as…
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FDA approval · 2025-04-01FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)
FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrillex) submitted by Strategic Sourcing Services LLC. …
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FDA approval · 2025-03-17FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE (nicotine polacrilex) filed by Haleon US Holdings LLC, updating/expanding the product'…
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FDA approval · 2025-03-06FDA Approved: BUPROPION — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved Zydus Pharmaceuticals USA Inc.'s supplemental application for Bupropion (ANDA 201567), enabling a generic version of the antide…
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FDA approval · 2025-02-11FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application to authorize Lupin Pharmaceuticals' generic Bupropion Hydrochloride XL.
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FDA approval · 2024-10-01FDA Approved: VARENICLINE TARTRATE — Original Application (Dr. Reddys Laboratories Inc.)
FDA approved the original application for varenicline tartrate from Dr. Reddy's Laboratories Inc., approving a generic version of the smokin…
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FDA approval · 2024-09-06FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
The FDA approved a supplemental application for Nicorette (nicotine polacrilex) submitted by Haleon US Holdings LLC.
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FDA approval · 2024-07-23FDA 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…
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FDA approval · 2024-07-12FDA 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 · 2024-05-07FDA Approved: BUPROPION HYDROCHLORIDE (SR) — Supplemental Application (ScieGen Pharmaceuticals, Inc.)
FDA approved ScieGen Pharmaceuticals' supplemental application for a generic bupropion hydrochloride sustained-release product, expanding ac…
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FDA approval · 2024-05-07FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)
The FDA approved a supplemental application for a generic form of bupropion hydrochloride from Apnar Pharma LP, allowing continued marketing…
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FDA approval · 2024-04-30FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE (nicotine polacrilex) submitted by Haleon US Holdings LLC.
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FDA approval · 2024-04-03FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bupropion hydrochloride sustained-release (Actavis) under an ANDA, approving the supplemental fi…
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FDA approval · 2024-03-19FDA Approved: VARENICLINE — Original Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s Original Application for a generic varenicline tartrate tablet indicated to aid in smoking cessation.
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FDA approval · 2024-03-15FDA 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 · 2024-03-15FDA 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…
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FDA approval · 2024-03-15FDA 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.
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FDA approval · 2024-03-15FDA 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…
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FDA approval · 2024-03-15FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)
FDA approved a supplemental application for Equate Nicotine (nicotine polacrilex) from Wal-Mart Stores Inc, confirming its use as a nicotine…