Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074507
Company: P AND L
Company: P AND L
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 03/15/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-507_Nicotine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74507ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-507_Nicotine.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2017 | SUPPL-59 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2015 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/28/2013 | SUPPL-53 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/23/2007 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 03/02/2009 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 12/08/2006 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/08/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 05/25/2004 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/10/2003 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/15/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/2002 | SUPPL-20 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/15/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/2002 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/30/2002 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/19/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/27/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/31/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/22/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-507_Nicotine_prntlbl.pdf |
NICOTINE POLACRILEX
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 |