Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076776
Company: L PERRIGO CO
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 | Discontinued | 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/2004/076776_NICOTINE_POLACRILEX_ORIGINAL_AP.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/29/2012 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2010 | SUPPL-14 | Labeling-Package Insert |
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. |