Tobacco Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-03-15FDA 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.
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FDA approval · 2024-03-15FDA 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…
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FDA approval · 2024-03-15FDA 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…
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FDA approval · 2024-03-06FDA Approved: VARENICLINE — Original Application (Marlex Pharmaceuticals, Inc.)
FDA approved Marlex Pharmaceuticals' original application for varenicline tartrate, a smoking cessation aid.
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FDA approval · 2024-02-29FDA 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.
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FDA approval · 2024-01-03FDA 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.
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FDA approval · 2023-10-23FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for Bupropion hydrochloride extended-release (XL), manufactured by Epic Pharma, LLC.
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FDA approval · 2023-09-21FDA Approved: CAREONE NICOTINE — Supplemental Application (American Sales Company)
The FDA approved a supplemental application for CAREONE NICOTINE (nicotine polacrilex) submitted by American Sales Company. The product is a…
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FDA approval · 2023-09-21FDA Approved: TOPCARE NICOTINE — Supplemental Application (Topco Associates LLC)
FDA supplemental approval for Topcare Nicotine (nicotine polacrilex) under an ANDA filed by Topco Associates LLC.
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FDA approval · 2023-08-23FDA Approved: VARENICLINE — Original Application (AvKARE)
FDA approves AvKARE's original application for a generic varenicline tartrate product used to aid smoking cessation.
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FDA approval · 2023-08-08FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application to market a generic form of bupropion hydrochloride, indi…
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FDA approval · 2023-08-01FDA 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…
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FDA approval · 2023-07-28FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Dr. Reddys Laboratories Inc.)
FDA approved a supplemental application for Dr. Reddy's Laboratories' generic Bupropion Hydrochloride SR, expanding its regulatory approval …
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FDA approval · 2023-02-07FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a supplemental application for Bupropion hydrochloride from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), rep…
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FDA approval · 2023-01-25FDA Approved: VARENICLINE — Original Application (Apotex Corp)
The FDA approved Apotex Corp's generic varenicline under an Original Abbreviated New Drug Application for smoking-cessation use.
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FDA approval · 2022-12-21FDA Approved: NICOTINE POLACRILEX GUM — Original Application (Fertin Pharma A/S)
FDA approved Fertin Pharma A/S's Nicotine Polacrilex Gum as an original application for the treatment of nicotine dependence and to aid smok…
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FDA approval · 2022-06-28FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved a supplemental application from Granules Pharmaceuticals Inc. to approve a bupropion hydrochloride granule formulation unde…
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FDA approval · 2022-06-14FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for bupropion hydrochloride from Rising Pharma Holdings, Inc., authorizing the generic product's…
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FDA approval · 2022-01-03FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Slate Run Pharmaceuticals, LLC)
The FDA approved a supplemental application for Bupropion Hydrochloride XL from Slate Run Pharmaceuticals, LLC.
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FDA approval · 2021-11-09FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE (nicotine polacrilex), a nicotine replacement therapy, submitted by Haleon US Holdings…
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FDA approval · 2021-10-15FDA Approved: TYRVAYA — Original Application (Oyster Point Pharma, Inc.)
FDA approved TYRVAYA (varenicline nasal spray) through an Original NDA from Oyster Point Pharma, establishing a nasal spray formulation for …
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FDA approval · 2021-08-11FDA Approved: VARENICLINE — Original Application (ENDO USA, Inc.)
The FDA approved Endo USA, Inc.'s original application for varenicline tartrate, a generic smoking-cessation medication.
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FDA approval · 2021-04-23FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application to market NICORETTE 4 mg Fruit Chill Gum (nicotine polacrilex) by Lil' Drug Store Products, Inc.
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FDA approval · 2021-03-12FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Solco Healthcare US LLC)
The FDA approved a supplemental application for a generic version of Bupropion hydrochloride sustained-release from Solco Healthcare US LLC …
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FDA approval · 2021-01-04FDA Approved: BUPROPION HYDROCHLORIDE (SR) — Supplemental Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s supplemental application for Bupropion hydrochloride sustained-release, enabling the generic product to be…