Drugs@FDA: FDA-Approved Drugs
Company: L PERRIGO CO
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 |
---|---|---|---|---|---|---|---|
09/16/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076789_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/15/2024 | SUPPL-31 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/17/2017 | SUPPL-23 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/15/2015 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
11/29/2012 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
08/30/2011 | SUPPL-18 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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06/17/2010 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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08/15/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
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07/15/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
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 |