Smoking Cessation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-25FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)
FDA approved a supplemental application for bupropion hydrochloride from Apnar Pharma LP, granting approval for the supplemental use of this…
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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 · 2025-12-18FDA Approved: VARENICLINE TARTRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Lupin Pharmaceuticals’ varenicline tartrate product, indicating approval of a change to the appr…
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FDA approval · 2025-11-06FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for Bupropion Hydrochloride (generic) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals …
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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 · 2025-06-24FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approves a supplemental application for CHANTIX (varenicline tartrate) from Pfizer Laboratories Div Pfizer Inc.
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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 · 2025-03-14FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for bupropion hydrochloride from Micro Labs Limited.
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FDA approval · 2025-01-29FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for Bupropion hydrochloride by Alembic Pharmaceuticals Limited under the ANDA pathway, authorizing t…
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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 · 2024-11-21FDA 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 · 2024-05-07FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for Bupropion hydrochloride from Micro Labs Limited under ANDA207403, signaling regulatory approval …
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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 · 2024-03-15FDA Approved: DG HEALTH NICOTINE — Supplemental Application (Dolgencorp Inc)
The FDA approved a supplemental application for DG Health Nicotine (nicotine polacrilex) submitted by Dolgencorp Inc, updating regulatory st…
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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) by Wal-Mart Stores Inc, approving a store-brand nicotine r…
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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…
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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 · 2024-03-06FDA 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 · 2024-01-03FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC. This action represents reg…
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FDA approval · 2023-10-23FDA Approved: VARENICLINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for a generic varenicline tartrate tablet indicated for smoking cessation.
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FDA approval · 2023-07-18FDA Approved: VARENICLINE — Supplemental Application (Apotex Corp)
The FDA approved a supplemental application for varenicline submitted by Apotex Corp, bringing a generic varenicline product to market.
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FDA approval · 2023-01-09FDA Approved: BUPROPION HYDROCHLORIDE SR — Original Application (Epic Pharma, LLC)
FDA approved Epic Pharma's generic bupropion hydrochloride sustained-release (BHCl SR) under an Original Application.
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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…