Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074707
Company: P AND L
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
03/19/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine%20Polacrilex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74707ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2017 SUPPL-54 Labeling-Package Insert

Label is not available on this site.

04/30/2015 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

02/22/2013 SUPPL-48 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/23/2007 SUPPL-36 Labeling

Label is not available on this site.

03/02/2009 SUPPL-34 Labeling

Label is not available on this site.

12/08/2006 SUPPL-30 Labeling

Label is not available on this site.

03/08/2007 SUPPL-28 Labeling

Label is not available on this site.

05/25/2004 SUPPL-23 Labeling

Label is not available on this site.

10/15/2002 SUPPL-20 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/15/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

03/30/2002 SUPPL-16 Labeling

Label is not available on this site.

02/19/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

08/08/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/2001 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/2000 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/27/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/19/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine%20Polacrilex_prntlbl.pdf

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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