Nicotine Dependence
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-05FDA Approved: NICOTINE — Supplemental Application (McKesson Corporation dba SKY Packaging)
FDA approved a supplemental application for NICOTINE (nicotine polacrilex) submitted by McKesson Corporation dba SKY Packaging.
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FDA approval · 2026-01-09FDA Approved: VARENICLINE — Original Application (Umedica Laboratories USA Inc.)
The FDA approved an original ANDA for varenicline from Umedica Laboratories USA Inc., authorizing a generic version of the smoking-cessation…
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FDA approval · 2025-11-06FDA Approved: BUPROPION HYDROCHLORIDE (SR) — Supplemental Application (ScieGen Pharmaceuticals, Inc.)
FDA approved ScieGen Pharmaceuticals’ supplemental application for Bupropion Hydrochloride (SR). The approval updates the labeling for the s…
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FDA approval · 2025-11-06FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for a generic bupropion hydrochloride product by Alembic Pharmaceuticals Limited.
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FDA approval · 2025-11-06FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (CIPLA USA INC.,)
FDA approved a supplemental application for bupropion hydrochloride from CIPLA USA INC., under the generic drug approval pathway.
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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 · 2025-10-06FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for Bupropion hydrochloride from Micro Labs Limited.
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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 · 2025-05-23FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Slate Run Pharmaceuticals, LLC)
The FDA approved a supplemental application for Bupropion hydrochloride XL from Slate Run Pharmaceuticals, approving the extended-release fo…
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FDA approval · 2025-05-02FDA Approved: VARENICLINE — Original Application (Aurobindo Pharma Limited)
The FDA approved a generic version of varenicline from Aurobindo Pharma Limited via an Original Application (ANDA) for smoking cessation.
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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 · 2025-03-24FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for Bupropion Hydrochloride (generic) from Amneal Pharmaceuticals of New York 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 · 2025-03-13FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA granted approval of a supplemental application for bupropion hydrochloride from Aurobindo Pharma Limited.
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FDA approval · 2025-01-29FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Solco Healthcare US LLC)
FDA approved a supplemental application for Bupropion Hydrochloride sustained-release from Solco Healthcare US LLC, indicating approval of a…
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FDA approval · 2025-01-29FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for a generic form of bupropion hydrochloride from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2024-12-19FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Oryza pharmaceuticals Inc.)
The FDA approved a supplemental application for Bupropion Hydrochloride XL from Oryza Pharmaceuticals Inc., confirming the extended-release …
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FDA approval · 2024-12-17FDA Approved: BUPROPION HYDROCHLORIDE (XL) — Supplemental Application (Vitruvias Therapeutics)
FDA approved a supplemental application for Bupropion Hydrochloride Extended-Release (XL) from Vitruvias Therapeutics under ANDA208652, appr…
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FDA approval · 2024-12-09FDA Approved: VARENICLINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's original application for varenicline as a generic version for smoking cessation.
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FDA approval · 2024-11-26FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for bupropion hydrochloride from Sun Pharmaceutical Industries, Inc. (generic).
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FDA approval · 2024-11-06FDA 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.
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FDA approval · 2024-10-29FDA Approved: VARENICLINE TARTRATE — Original Application (Indoco Remedies Limited)
FDA approved the original application for varenicline tartrate from Indoco Remedies Limited. This approval provides a generic option for smo…
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FDA approval · 2024-10-23FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental ANDA for Bupropion hydrochloride extended-release (XL) from Actavis Pharma, confirming the generic product's app…
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FDA approval · 2024-10-17FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals' generic bupropion hydrochloride through an original New Drug Application (ANDA), confirming its use f…
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FDA approval · 2024-10-07FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Epic Pharma, LLC)
FDA approved Epic Pharma's supplemental application for bupropion hydrochloride extended-release (XL), confirming the approval of a generic …