Nicotine Dependence
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-10-07FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for bupropion hydrochloride from Actavis Pharma, Inc., indicating an approved change to the gene…
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FDA approval · 2020-08-04FDA Approved: NICOTINE POLACRILEX — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Dr. Reddy's Laboratories' Nicotine Polacrilex as a generic nicotine polacrilex gum for aiding smoking cessation.
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FDA approval · 2020-07-10FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for a generic Bupropion Hydrochloride Extended-Release (XL) product.
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FDA approval · 2020-06-30FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Bupropion Hydrochloride from Rising Pharma Holdings, Inc., for a generic product under an AN…
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FDA approval · 2020-05-14FDA Approved: NICOTINE MINI — Original Application (CVS Pharmacy)
FDA approved CVS Pharmacy's Nicotine Mini lozenge containing nicotine polacrilex under an original application, expanding access to nicotine…
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FDA approval · 2020-04-24FDA Approved: TOPCARE NICOTINE — Supplemental Application (Topco Associates LLC)
FDA approved a supplemental application for TOPCARE NICOTINE (nicotine polacrilex) from Topco Associates LLC. This action updates the labeli…
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FDA approval · 2020-02-21FDA Approved: NICOTINE POLACRILEX — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Dr. Reddy's NICOTINE POLACRILEX (nicotine polacrilex) as a generic nicotine gum for smoking cessation.
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FDA approval · 2020-01-08FDA Approved: NICOTINE POLACRILEX — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved the original application (ANDA) for Nicotine Polacrilex from Dr. Reddy's Laboratories Inc., a generic nicotine replacement ther…
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FDA approval · 2019-12-27FDA Approved: NICOTINE MINI — Supplemental Application (Walgreen Company)
FDA approved a supplemental application for NICOTINE MINI (nicotine polacrilex), submitted by Walgreens, under ANDA203690.
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FDA approval · 2019-12-10FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved Upsher-Smith Laboratories' supplemental application for bupropion hydrochloride, updating the product labeling.
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FDA approval · 2019-11-01FDA Approved: EQUATE NICOTINE — Supplemental Application (Wal-Mart Stores Inc)
FDA approved a supplemental application for Equate Nicotine (nicotine polacrilex) from Wal-Mart Stores Inc. This action updates the regulato…
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FDA approval · 2019-11-01FDA Approved: NICOTINE — Supplemental Application (H E B)
FDA approved a supplemental application for NICOTINE (nicotine and nicotine polacrilex) from H E B.
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FDA approval · 2019-10-31FDA Approved: NICOTINE MINI — Original Application (Advagen Pharma Limited)
The FDA approved Advagen Pharma Limited's NICOTINE MINI (nicotine polacrilex gum) under an original application.
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FDA approval · 2019-10-31FDA Approved: NICOTINE MINI — Original Application (Walgreens)
FDA overview of Walgreens' NICOTINE MINI, an original Abbreviated New Drug Application for nicotine polacrilex.
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FDA approval · 2019-09-06FDA Approved: MAXI NICOTINE — Original Application (Walgreens)
The FDA approved MAXI NICOTINE (nicotine polacrilex) under an original application (Walgreens) as a nicotine replacement therapy product.
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FDA approval · 2019-08-29FDA Approved: NICOTROL — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for NICOTROL (nicotine) from Pharmacia & Upjohn Company LLC, indicating regulatory approval of c…
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FDA approval · 2019-07-26FDA Approved: NICOTINE — Original Application (Rite Aid Corporation)
FDA approved Rite Aid's generic nicotine polacrilex under an Original Application (ANDA) for smoking cessation.
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FDA approval · 2019-02-07FDA Approved: MINI NICOTINE — Original Application (P & L Development, LLC)
FDA approved the original ANDA for MINI NICOTINE (nicotine polacrylex) by P & L Development, LLC, a nicotine replacement therapy product. Th…
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FDA approval · 2019-01-28FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original application for bupropion hydrochloride as a generic drug. The approval was issued to Rising Pharma Holdings, Inc.
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FDA approval · 2019-01-02FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Dr. Reddys Laboratories Inc.)
FDA approved a supplemental application for the Nicotine Transdermal System from Dr. Reddys Laboratories Inc. under NDA 020076. The action r…
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FDA approval · 2018-11-14FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
The FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM by Lil' Drug Store Products, confirming continued marketing of…
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FDA approval · 2018-11-01FDA Approved: NICOTINE MINI — Supplemental Application (Walgreen Company)
FDA approves a supplemental application for NICOTINE MINI (nicotine polacrilex) submitted by Walgreens Company.
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FDA approval · 2018-10-31FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for a generic bupropion hydrochloride product. The approval supports use for major dep…
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FDA approval · 2018-10-16FDA Approved: BUPROPION HYDROCHLORIDE SR — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approves the original generic application for Bupropion Hydrochloride SR, enabling Slate Run Pharmaceuticals to market a generic sustain…
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FDA approval · 2018-08-10FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE (nicotine polacrilex) from Haleon US Holdings LLC.