Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076568
Company: ACTAVIS LABS NY INC
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
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
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
04/14/2017 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

04/30/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/28/2013 SUPPL-25 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/16/2007 SUPPL-10 Labeling

Label is not available on this site.

12/08/2006 SUPPL-3 Labeling

Label is not available on this site.

03/08/2007 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 074707 ACTAVIS LABS NY INC
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 076568 ACTAVIS LABS NY INC
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 078697 ACTAVIS LABS NY INC
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079038 ACTAVIS LABS NY INC
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 079219 ACTAVIS LABS NY INC
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING;BUCCAL Over-the-counter No 204833 ACTAVIS LABS NY INC
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 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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