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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076568
Company: P AND L

Products on ANDA 076568

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076568

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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	HALEON US HOLDINGS
NICORETTE (MINT)	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING;BUCCAL	Over-the-counter	Yes	020066	HALEON US HOLDINGS
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	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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