Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022360
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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 03/05/2021 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022360Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022360Orig1s012ltr.pdf | |
| 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-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/05/2021 | SUPPL-12 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022360Orig1s012lbl.pdf | |
| 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 | 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 |