Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021330
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter None Yes No
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21330ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-330_Commit.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2018 SUPPL-21 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021330Orig1s021bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21330Orig1s021ltr.pdf
08/10/2015 SUPPL-20 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s020ltr.pdf
09/30/2015 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s019ltr.pdf
05/18/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s018ltr.pdf
08/14/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021330Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021330Orig1s017ltr.pdf
10/28/2013 SUPPL-16 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021330Orig1s016ltr.pdf
08/07/2013 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021330Orig1s015ltr.pdf
03/08/2013 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021330Orig1S014.pdf
05/23/2012 SUPPL-13 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021330s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021330Orig1s013.pdf
08/27/2010 SUPPL-9 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s009ltr.pdf
01/05/2010 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s008ltr.pdf
05/23/2008 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021330s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021330Orig1s007.pdf
09/01/2006 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021330s005ltr.pdf
11/22/2005 SUPPL-4 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021330s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021330Orig1s004.pdf
10/25/2005 SUPPL-3 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021330s003ltr.pdf
02/13/2004 SUPPL-2 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21330scf002_committ_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21330scf002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021330Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2018 SUPPL-21 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021330Orig1s021bl.pdf
09/30/2015 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330s019lbl.pdf
08/10/2015 SUPPL-20 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s020lbl.pdf
05/18/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s018lbl.pdf
08/14/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021330Orig1s017lbl.pdf
10/28/2013 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330Orig1s016lbl.pdf
09/01/2006 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf
09/01/2006 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf
11/22/2005 SUPPL-4 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s004lbl.pdf
10/25/2005 SUPPL-3 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s003lbl.pdf
02/13/2004 SUPPL-2 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21330scf002_committ_lbl.pdf

NICORETTE

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

TROCHE/LOZENGE;ORAL; EQ 4MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter Yes 021330 GLAXOSMITHKLINE CONS
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter Yes 022360 GLAXOSMITHKLINE CONS
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 208875 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 209520 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 210711 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 210712 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 212056 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 077007 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 090711 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 090821 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 203690 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 207868 PLD ACQUISITIONS

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

TROCHE/LOZENGE;ORAL; EQ 2MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter Yes 021330 GLAXOSMITHKLINE CONS
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter Yes 022360 GLAXOSMITHKLINE CONS
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 208875 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 209520 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 210711 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 210712 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 212056 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 077007 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 090711 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 090821 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 203690 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 207868 PLD ACQUISITIONS

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