Application 018612

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NICORETTE	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 2MG BASE	Yes	No
003	NICORETTE (MINT)	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 2MG BASE	Yes	No
004	NICORETTE	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 2MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018612-002	NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09
N018612-003	NICORETTE (MINT)	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23
N018612-004	NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N018612-002	8323683	2028-04-30			2013-01-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018612-003	NICORETTE (MINT)	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1998-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018612-004	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	2000-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018612-002	NICORETTE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	RLD	1996-02-09	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018612-002	8323683	2028-04-30	2013-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018612-002	8323683	2028-04-30	2013-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018612-002	8323683	2028-04-30	2013-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018612-002	8323683	2028-04-30	2013-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018612-002	8323683	2028-04-30	2013-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018612-002	8323683	2028-04-30	2013-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018612-002	8323683	2028-04-30	2013-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018612-002	8323683	2028-04-30	2013-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018612-002	8323683	2028-04-30	2013-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018612-002	8323683	2028-04-30	2013-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018612-002	8323683	2028-04-30	2013-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018612-002	8323683	2028-04-30	2013-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018612-002	8323683	2028-04-30	2013-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018612-002	8323683	2028-04-30	2013-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018612-002	8323683	2028-04-30	2013-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018612-002	8323683	2028-04-30	2013-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018612-002	8323683	2028-04-30	2013-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018612-002	8323683	2028-04-30	2013-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018612-002	8323683	2028-04-30	2013-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018612-002	8323683	2028-04-30	2013-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018612-002	8323683	2028-04-30	2013-01-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018612-002	8323683	2028-04-30	2013-01-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018612-002	8323683	2028-04-30	2013-01-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018612-002	8323683	2028-04-30	2013-01-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018612-002	8323683	2028-04-30	2013-01-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018612-002	8323683	2028-04-30	2013-01-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018612-002	8323683	2028-04-30	2013-01-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018612-002	8323683	2028-04-30	2013-01-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018612-002	8323683	2028-04-30	2013-01-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018612-002	8323683	2028-04-30	2013-01-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018612-002	8323683	2028-04-30	2013-01-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018612-002	8323683	2028-04-30	2013-01-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018612-002	8323683	2028-04-30	2013-01-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018612-002	8323683	2028-04-30	2013-01-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018612-002	8323683	2028-04-30	2013-01-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018612-002	8323683	2028-04-30	2013-01-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018612-002	8323683	2028-04-30	2013-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018612-002	8323683	2028-04-30	2013-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018612-002	8323683	2028-04-30	2013-01-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018612-002	8323683	2028-04-30	2013-01-03	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicorette Original	NICOTINE POLACRILEX	Haleon US Holdings LLC	673fd19f-69b3-4f73-b9b4-18b5f4cbf69c	2024-08-13	Warnings	Exact identifier application applno (NDA): 018612 application number: NDA018612 ndc (product): 0135-0157 ndc (product): 0135-0532 ndc (product): 0135-0229 ndc (product): 0135-0474 ndc (product): 0135-0466
Nicorette Fruit Chill	NICOTINE POLACRILEX	Haleon US Holdings LLC	a0206139-59c6-44c3-963c-8cb5f2d69075	2024-07-29	Warnings	Exact identifier application applno (NDA): 018612 application number: NDA018612 ndc (product): 0135-0241

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0157	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0157	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0225	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0225	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0229	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0229	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0241	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0241	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0466	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0466	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0474	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0474	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0532	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0532	Nicorette	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
11673-229	NICOTINE POLACRILEX	nicotine polacrilex	Target Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77184	SUPPL	2024-01-04
77179	SUPPL	2024-01-04
67476	SUPPL	2021-05-13
67183	SUPPL	2021-04-27
56535	SUPPL	2018-11-21
56485	SUPPL	2018-11-16
54650	SUPPL	2018-06-21
54550	SUPPL	2018-06-14
50747	SUPPL	2017-12-18
49988	SUPPL	2017-10-10
33523	SUPPL	2015-11-02
15047	SUPPL	2015-10-02
11248	SUPPL	2014-11-07
15046	SUPPL	2014-11-03
33522	SUPPL	2014-08-05
11247	SUPPL	2014-08-05
15045	SUPPL	2014-06-12
972	SUPPL	2014-06-12
33520	SUPPL	2014-01-16
33521	SUPPL	2013-11-07
15044	SUPPL	2013-10-31
971	SUPPL	2012-07-18
33519	SUPPL	2012-03-28
20133	SUPPL	2012-03-27
970	SUPPL	2012-02-17
969	SUPPL	2012-02-03
968	SUPPL	2011-09-29
967	SUPPL	2011-05-19
15043	SUPPL	2009-05-08
966	SUPPL	2008-06-16
20132	SUPPL	2007-07-06
15042	SUPPL	2007-07-05
33518	SUPPL	2007-06-27
965	SUPPL	2006-05-05
11246	SUPPL	2005-12-13
964	SUPPL	2005-12-13
20130	SUPPL	2005-05-02
15041	SUPPL	2004-06-24
963	SUPPL	2004-06-23
15040	SUPPL	2004-04-29
962	SUPPL	2002-08-09
33517	SUPPL	1998-12-23
20131	SUPPL	1998-12-23
961	SUPPL	1998-12-23