Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076880
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
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 |
---|---|---|---|---|---|---|---|
02/18/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076880Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/19/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |