Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/13/1984 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/14/2018 SUPPL-81 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s062,018612Orig1s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020066Orig1s062, 018612Orig1s081ltr.pdf
06/05/2018 SUPPL-80 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s061,018612Orig1s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020066Orig1s061,018612Orig1s080ltr.pdf
12/11/2017 SUPPL-79 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020066Orig1s060,018612Orig1s079ltr.pdf
09/11/2017 SUPPL-78 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf
09/10/2015 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

09/30/2015 SUPPL-76 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf
01/05/2015 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-74 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066Orig1s055ltr.pdf
06/11/2014 SUPPL-73 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf
06/11/2014 SUPPL-72 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf
02/21/2014 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

04/17/2014 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

10/11/2013 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

10/30/2013 SUPPL-68 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066Orig1s049ltr.pdf
08/01/2012 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/16/2012 SUPPL-65 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612Orig1s065,020066Orig1s046ltr.pdf
02/15/2012 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s061,020066s042ltr.pdf
02/01/2012 SUPPL-60 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf
09/12/2011 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

09/27/2011 SUPPL-57 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s057ltr.pdf
05/17/2011 SUPPL-56 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s056,020066s037ltr.pdf
05/06/2009 SUPPL-52 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033ltr.pdf
04/21/2010 SUPPL-51 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/13/2008 SUPPL-50 Labeling-Package Insert Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050, 020066s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/018612Orig1s050.pdf
06/26/2007 SUPPL-49 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018612s049, 020066s030ltr.pdf
05/04/2006 SUPPL-43 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018612s043,020066s024LTR.pdf
12/02/2005 SUPPL-42 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023ltr.pdf
06/18/2004 SUPPL-37 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf037ltr.pdf
06/23/2004 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612slr035ltr.pdf
04/23/2004 SUPPL-34 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018612_S034_NICORETTE_GUM_AP.pdf
11/15/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2002 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066slr013ltr.pdf
09/25/2000 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/24/2001 SUPPL-26 Labeling

Label is not available on this site.

12/23/1998 SUPPL-25 Efficacy-Accelerated Approval Confirmatory Study Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612s025_Nicorette.cfm
11/04/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1996 SUPPL-22 Efficacy-Rx To OTC Switch Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018612s022_020066s004_Nicorette.cfm
08/22/1991 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1991 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/17/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/23/1985 SUPPL-8 Labeling

Label is not available on this site.

09/12/1988 SUPPL-7 Labeling

Label is not available on this site.

02/26/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/12/1988 SUPPL-3 Labeling

Label is not available on this site.

03/02/1984 SUPPL-2 Labeling

Label is not available on this site.

02/21/1984 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
06/26/2007 SUPPL-49 Labeling-Container/Carton Labels 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

NICORETTE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GUM, CHEWING;BUCCAL; EQ 2MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076775 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076776 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076777 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074507 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076569 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078699 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079044 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079216 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204794 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078325 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078547 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078967 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091349 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206394 PERRIGO R AND D

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GUM, CHEWING;BUCCAL; EQ 2MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076775 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076776 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076777 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074507 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076569 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078699 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079044 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079216 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204794 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078325 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078547 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078967 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091349 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206394 PERRIGO R AND D

NICORETTE (MINT)

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GUM, CHEWING;BUCCAL; EQ 2MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076775 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076776 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076777 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074507 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076569 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078699 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079044 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079216 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204794 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078325 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078547 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078967 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091349 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206394 PERRIGO R AND D

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