Drugs@FDA: FDA-Approved Drugs
Company: P AND L
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG 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 |
---|---|---|---|---|---|---|---|
03/19/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine%20Polacrilex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74707ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2017 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
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04/30/2015 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
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02/22/2013 | SUPPL-48 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/23/2007 | SUPPL-36 | Labeling |
Label is not available on this site. |
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03/02/2009 | SUPPL-34 | Labeling |
Label is not available on this site. |
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12/08/2006 | SUPPL-30 | Labeling |
Label is not available on this site. |
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03/08/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
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05/25/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
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10/15/2002 | SUPPL-20 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/15/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/15/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/15/2002 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/30/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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02/19/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/08/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/23/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/26/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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12/27/1999 | 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 |
---|---|---|---|---|---|
03/19/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine%20Polacrilex_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 4MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NICORETTE | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 020066 | HALEON US HOLDINGS |
NICORETTE (MINT) | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 020066 | HALEON US HOLDINGS |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 076779 | L PERRIGO CO |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 076789 | L PERRIGO CO |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 074707 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 076568 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 078697 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 079038 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 079219 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 204833 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 078326 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 078546 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 091354 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 206393 | PERRIGO R AND D |