Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020066
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter None Yes Yes
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter None Yes No
NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG 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
06/08/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

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-62 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-61 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-60 Labeling-Container/Carton Labels Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020066Orig1s060,018612Orig1s079ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020066Orig1s060,018612Orig1s079ltr.pdf
09/11/2017 SUPPL-59 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf
09/30/2015 SUPPL-57 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020066s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf
10/30/2014 SUPPL-55 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-54 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-53 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
04/17/2014 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

10/30/2013 SUPPL-49 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-48 Manufacturing (CMC)

Label is not available on this site.

07/16/2012 SUPPL-46 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-42 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-41 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf
09/27/2011 SUPPL-38 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020066s038ltr.pdf
05/17/2011 SUPPL-37 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-33 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-32 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/13/2008 SUPPL-31 Labeling-Container/Carton Labels, 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/2008/020066Orig1s031.pdf
06/26/2007 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert 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-24 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-23 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-19 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf019ltr.pdf
06/23/2004 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066slr017ltr.pdf
04/23/2004 SUPPL-16 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020066_S016_NICORETTE_GUM_AP.pdf
11/15/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2002 SUPPL-13 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-10 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066s10_Nicorette.cfm
08/24/2001 SUPPL-8 Labeling

Label is not available on this site.

12/23/1998 SUPPL-7 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-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1996 SUPPL-4 Efficacy-Rx To OTC Switch

Label is not available on this site.

03/22/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/22/1993 SUPPL-1 Manufacturing (CMC)

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-62 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s062,018612Orig1s081lbl.pdf
06/05/2018 SUPPL-61 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s061,018612Orig1s080lbl.pdf
09/11/2017 SUPPL-59 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf
09/30/2015 SUPPL-57 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020066s057lbl.pdf
10/30/2014 SUPPL-55 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf
06/11/2014 SUPPL-54 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf
06/11/2014 SUPPL-53 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf
10/30/2013 SUPPL-49 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf
07/16/2012 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf
02/15/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf
06/26/2007 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
06/26/2007 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
12/02/2005 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf
09/25/2000 SUPPL-10 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_prntlbl.pdf
12/23/1998 SUPPL-7 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 4MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076778 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076779 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076789 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074707 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076568 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078697 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079038 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079219 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204833 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078326 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078546 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078968 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091354 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206393 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 4MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076778 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076779 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076789 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074707 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076568 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078697 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079038 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079219 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204833 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078326 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078546 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078968 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091354 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206393 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 4MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076778 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076779 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076789 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074707 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076568 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078697 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079038 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079219 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204833 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078326 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078546 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078968 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091354 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206393 PERRIGO R AND D

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