Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078967
Company: PERRIGO R AND D
Company: PERRIGO R AND D
| 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/27/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/17/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |