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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078967
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.

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.

06/17/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

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