Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022360
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
05/18/2009 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022360s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360_nicorette_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/05/2018 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022360ORig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022360ORig1s011ltr.pdf
09/30/2015 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s010ltr.pdf
04/16/2015 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s009ltr.pdf
02/14/2014 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022360Orig1s008.pdf
10/28/2013 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s007ltr.pdf
05/23/2013 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s006ltr.pdf
03/08/2013 SUPPL-5 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022360Orig1S005.pdf
09/18/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022360Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022360Orig1s004ltr.pdf
12/06/2011 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022360s002ltr.pdf
12/21/2009 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/05/2018 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022360ORig1s011lbl.pdf
09/30/2015 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360s010lbl.pdf
04/16/2015 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360Orig1s009lbl.pdf
10/28/2013 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf
05/23/2013 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf
09/18/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022360Orig1s004lbl.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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