Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021330
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 | 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 |
|---|---|---|---|---|---|
| 11/09/2021 | SUPPL-24 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021330Orig1s024Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021330Orig1s024ltr.pdf | |
| 08/10/2018 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021330Orig1s021bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21330Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/021330Orig1s021.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-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/2008/021330s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021330Orig1s007.pdf |
| 09/01/2006 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 11/09/2021 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021330Orig1s024Lbl.pdf | |
| 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf | |
| 09/01/2006 | SUPPL-5 | Labeling-Package Insert | 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 | HALEON US HOLDINGS |
| NICORETTE | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | Yes | 022360 | HALEON US HOLDINGS |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213266 | AUROBINDO PHARMA |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 215357 | AUROBINDO PHARMA LTD |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212796 | DR REDDYS LABS SA |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212983 | DR REDDYS LABS SA |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213233 | DR REDDYS LABS SA |
| 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 | 209206 | P AND L |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209519 | 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 | 212057 | 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 | HALEON US HOLDINGS |
| NICORETTE | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | Yes | 022360 | HALEON US HOLDINGS |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213266 | AUROBINDO PHARMA |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 215357 | AUROBINDO PHARMA LTD |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212796 | DR REDDYS LABS SA |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212983 | DR REDDYS LABS SA |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213233 | DR REDDYS LABS SA |
| 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 | 209206 | P AND L |
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209519 | 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 | 212057 | 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 |