Nicotine Dependence
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-02-08FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (CIPLA USA INC.,)
FDA approved a supplemental application for Bupropion hydrochloride submitted by Cipla USA Inc., reflecting a regulatory action on an existi…
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FDA approval · 2023-02-07FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Cadila Pharmaceuticals Limited)
FDA approved a supplemental application for bupropion hydrochloride submitted by Cadila Pharmaceuticals Limited.
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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 · 2022-09-02FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)
FDA approved a supplemental application for bupropion hydrochloride from Epic Pharma LLC, indicating approval of a generic formulation.
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FDA approval · 2022-06-23FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Slate Run Pharmaceuticals, LLC)
The FDA approved a supplemental application for a generic Bupropion hydrochloride sustained-release product from Slate Run Pharmaceuticals, …
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FDA approval · 2022-05-13FDA Approved: AMAZON BASIC CARE NICOTINE POLACRILEX — Original Application (Amazon.com Services LLC)
FDA approved the original application for Amazon Basic Care Nicotine Polacrilex Mini, a nicotine replacement product intended to aid smoking…
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FDA approval · 2022-03-04FDA 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. This action co…
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FDA approval · 2022-02-02FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Bupropion hydrochloride as an original-application generic product by Granules Pharmaceuticals Inc.; the product is indicated f…
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FDA approval · 2022-01-06FDA Approved: TOPCARE NICOTINE — Supplemental Application (Topco Associates LLC)
FDA approved a supplemental application for TOPCARE NICOTINE (nicotine polacrilex) from Topco Associates LLC.
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FDA approval · 2022-01-05FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for bupropion hydrochloride from Sun Pharmaceutical Industries, authorizing the generic product’s ma…
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FDA approval · 2021-12-13FDA Approved: BUPROPION HYDROCHLORIDE (SR) — Supplemental Application (ScieGen Pharmaceuticals, Inc.)
FDA approved ScieGen Pharmaceuticals' supplemental application for a sustained-release generic version of bupropion hydrochloride, with the …
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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 · 2021-08-03FDA Approved: AMAZON BASIC CARE NICOTINE POLACRILEX — Original Application (Amazon.com Services LLC)
FDA approved a generic version of nicotine polacrilex lozenges under the Amazon Basic Care brand through an original ANDA. The medication is…
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FDA approval · 2021-04-23FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approves a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC.
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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 · 2021-03-05FDA 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 · 2021-01-04FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for Bupropion Hydrochloride from Amneal Pharmaceuticals of New York LLC, authorizing the generic pro…
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FDA approval · 2020-12-22FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Dr. Reddys Laboratories Inc.)
The FDA approved a supplemental application for Bupropion Hydrochloride SR, granting approval for the generic sustained-release formulation …
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FDA approval · 2020-12-15FDA Approved: NICOTINE POLACRILEX — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for NICOTINE POLACRILEX from Dr. Reddy's Laboratories, confirming continued approval of this nicotin…
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FDA approval · 2020-12-15FDA Approved: NICOTINE POLACRILEX — Supplemental Application (Dr. Reddy's Laboratories Inc.)
The FDA has approved a supplemental application for NICOTINE POLACRILEX from Dr. Reddy's Laboratories Inc.
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FDA approval · 2020-12-15FDA Approved: NICOTINE POLACRILEX — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for NICOTINE POLACRILEX (nicotine polacrilex) from Dr. Reddy's Laboratories Inc., enabling continued…
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FDA approval · 2020-10-29FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (CIPLA USA INC.,)
FDA approved a supplemental application for BUPROPION HYDROCHLORIDE from CIPLA USA INC., updating the existing approved product.
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FDA approval · 2020-10-16FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for BUPROPION HYDROCHLORIDE XL by Actavis Pharma, Inc. under the ANDA process for the extended-relea…