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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018612
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter None Yes No
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter None Yes No
NICORETTE (MINT) NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/23/2021 SUPPL-83 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018612Orig1s083,020066Orig1s065lbl.pdf
11/14/2018 SUPPL-81 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s062,018612Orig1s081lbl.pdf
06/05/2018 SUPPL-80 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s061,018612Orig1s080lbl.pdf
09/11/2017 SUPPL-78 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf
09/30/2015 SUPPL-76 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf
10/30/2014 SUPPL-74 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf
06/11/2014 SUPPL-73 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf
06/11/2014 SUPPL-72 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf
10/30/2013 SUPPL-68 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf
07/16/2012 SUPPL-65 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf
02/15/2012 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf
06/26/2007 SUPPL-49 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
06/26/2007 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
12/02/2005 SUPPL-42 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf
12/23/1998 SUPPL-25 Efficacy-Accelerated Approval Confirmatory Study Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf
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