Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078547
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 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
05/24/2007 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
03/25/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/28/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/25/2012 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

06/17/2010 SUPPL-7 Labeling-Package Insert

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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