Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076779
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG 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/2004/076779_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2014 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

11/29/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

10/31/2011 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

03/25/2010 SUPPL-19 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 4MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 020066 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076778 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076779 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076789 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074707 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076568 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078697 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079038 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079219 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204833 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078326 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078546 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078968 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091354 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206393 PERRIGO R AND D

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