Smoking Cessation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2009-11-16FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bupropion Hydrochloride SR from Actavis, a generic sustained-release formulation.
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FDA approval · 2009-11-05FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)
FDA approved a supplemental application for bupropion hydrochloride (Epic Pharma LLC) under ANDA 075932. This approval updates the approved …
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FDA approval · 2009-07-10FDA Approved: NICOTINE — Original Application (Walgreen Company)
FDA approved Walgreens' original application for nicotine polacrilex gum (nicotine replacement therapy) to aid adults in quitting smoking an…
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FDA approval · 2009-07-10FDA Approved: KIRKLAND SIGNATURE NICOTINE — Original Application (Costco Wholesale Company)
FDA approves Costco Wholesale Company's Kirkland Signature Nicotine (nicotine polacrilex) under an Original Application, making it available…
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FDA approval · 2009-07-08FDA Approved: NICOTINE — Original Application (P & L Development, LLC)
FDA approved NICOTINE POLACRILEX (nicotine polacrilex lozenges) from P & L Development, LLC under an original application (ANDA079044).
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FDA approval · 2009-05-18FDA Approved: NICORETTE — Original Application (Haleon US Holdings LLC)
FDA approved NICORETTE (nicotine polacrilex) under Original Application NDA022360 by Haleon US Holdings LLC for smoking cessation. NICORETTE…
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FDA approval · 2009-05-06FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC.
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FDA approval · 2009-05-06FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for Nicorette 4 mg Fruit Chill Gum from Lil' Drug Store Products, Inc. (nicotine polacrilex).
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FDA approval · 2009-03-02FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)
FDA approves a supplemental application for Rugby Nicotine Polacrilex Gum, Original Flavor, a generic nicotine replacement gum (ANDA).
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FDA approval · 2008-12-19FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)
The FDA approved a supplemental application for bupropion hydrochloride submitted by Apnar Pharma LP.
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FDA approval · 2008-07-09FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bupropion Hydrochloride XL, resulting in modifications to labeling/indications for the product.
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FDA approval · 2008-05-16FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Chantix (varenicline tartrate) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2008-04-14FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)
FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrilex), a nicotine replacement therapy, submitted by S…
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FDA approval · 2008-01-31FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Chantix (varenicline tartrate) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2007-11-20FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for CHANTIX (varenicline tartrate) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2007-09-17FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved Amneal's supplemental ANDA for generic bupropion hydrochloride, enabling marketing of a generic formulation.
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FDA approval · 2007-06-26FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) filed by Haleon US Holdings LLC.
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FDA approval · 2007-06-26FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM (nicotine polacrylex) from Lil' Drug Store Products, expanding the…
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FDA approval · 2007-06-04FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)
FDA approved a supplemental application for Bupropion Hydrochloride from Epic Pharma LLC, granting regulatory approval of this generic produ…
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FDA approval · 2007-04-13FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)
FDA approved a supplemental application for the Nicotine Transdermal System submitted by Sam's West Inc.
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FDA approval · 2007-03-08FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)
FDA approved a supplemental application for Rugby Nicotine Polacrilex Gum, Original Flavor, expanding its labeling for this nicotine replace…
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FDA approval · 2006-09-15FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)
FDA approved a supplemental application for the nicotine transdermal system (nicotine patch) filed by Sam's West Inc, updating the product's…
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FDA approval · 2006-05-05FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Dr. Reddys Laboratories Inc.)
FDA approved a supplemental application for the Nicotine Transdermal System (nicotine patch) from Dr. Reddys Laboratories Inc., maintaining/…
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FDA approval · 2006-05-04FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM by Lil' Drug Store Products, Inc., enabling market authorization o…