Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018612
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| 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 |
|---|---|---|---|---|---|
| 01/03/2024 | SUPPL-84 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018612Orig1s084;020066Orig1s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018612Orig1s084;020066Orig1s066ltr.pdf | |
| 04/23/2021 | SUPPL-83 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018612Orig1s083,020066Orig1s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018612Orig1s083; 020066Orig1s065ltr.pdf | |
| 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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 01/03/2024 | SUPPL-84 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018612Orig1s084;020066Orig1s066lbl.pdf | |
| 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-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 | HALEON US HOLDINGS |
| NICORETTE (MINT) | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 018612 | HALEON US HOLDINGS |
| 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 | 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 | 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 | HALEON US HOLDINGS |
| NICORETTE (MINT) | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 018612 | HALEON US HOLDINGS |
| 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 | 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 | 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 | HALEON US HOLDINGS |
| NICORETTE (MINT) | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 018612 | HALEON US HOLDINGS |
| 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 | 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 | 091349 | PERRIGO R AND D |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 206394 | PERRIGO R AND D |