An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074707
Company: P AND L

Products on ANDA 074707

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074707

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.

Labels for ANDA 074707

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

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

Top