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 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 |
---|---|---|---|---|---|---|---|
09/16/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076777_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-35 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
03/15/2024 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
03/27/2014 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
11/29/2012 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
10/31/2011 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076777Orig1s025BioeqR.pdf |
03/25/2010 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
06/13/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
08/15/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
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 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 |