Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076569
Company: P AND L
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter None No No
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG 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
07/29/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76568,76569ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2017 SUPPL-27 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/30/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/28/2013 SUPPL-21 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/23/2007 SUPPL-8 Labeling

Label is not available on this site.

12/08/2006 SUPPL-3 Labeling

Label is not available on this site.

04/22/2005 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 2MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICORETTE (MINT) NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter Yes 018612 GLAXOSMITHKLINE
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076775 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076776 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076777 L PERRIGO CO
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 074507 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076569 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078699 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079044 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079216 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204794 P AND L
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078325 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078547 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078967 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 091349 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 206394 PERRIGO R AND D

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