Application 022360

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICORETTE	NICOTINE POLACRILEX	TROCHE/LOZENGE;ORAL	EQ 2MG BASE	Yes	No
002	NICORETTE	NICOTINE POLACRILEX	TROCHE/LOZENGE;ORAL	EQ 4MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022360-001	NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL		RLD	2009-05-18
N022360-002	NICORETTE	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL		RLD, RS	2009-05-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022360-001	8940772	2029-04-30	Drug product	2015-02-25
N022360-001	8501164	2029-06-14	Drug product	2013-09-05
N022360-002	8940772	2029-04-30	Drug product	2015-02-25
N022360-002	8501164	2029-06-14	Drug product	2013-09-05

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`2680178bc6a6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicorette Peppermint	NICOTINE POLACRILEX	Haleon US Holdings LLC	990a4a65-d573-46a9-889d-60afb0018944	2025-07-31	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360
Nicorette Cherry Peppermint	NICOTINE POLACRILEX	Haleon US Holdings LLC	35438b53-2760-bcfe-e063-6394a90a65c0	2025-06-09	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	c7f32ab1-f6bd-46f5-9852-8eb5b78a3326	2025-04-25	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360 ndc (product): 0135-2800 ndc (product): 0135-1500
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	fdee1637-8049-4bc5-b196-b6d854c9f9f3	2024-03-05	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360 ndc (product): 0135-0508 ndc (product): 0135-0509

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0508	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0508	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0508	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0509	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0509	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0509	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-1500	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-2800	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
68151-5980	NICORETTE	nicotine polacrilex	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81632	SUPPL	2025-03-18
81631	SUPPL	2025-03-18
80309	SUPPL	2024-11-22
80274	SUPPL	2024-11-22
78345	SUPPL	2024-05-02
78335	SUPPL	2024-05-02
67816	SUPPL	2021-06-15
67798	SUPPL	2021-06-15
54652	SUPPL	2018-06-21
54551	SUPPL	2018-06-14
48856	SUPPL	2017-06-28
22002	SUPPL	2015-11-18
38618	SUPPL	2015-10-22
7293	SUPPL	2015-10-02
38617	SUPPL	2015-04-21
7292	SUPPL	2015-04-17
17290	SUPPL	2013-11-07
29644	SUPPL	2013-10-29
17289	SUPPL	2013-09-24
7291	SUPPL	2013-05-28
38616	SUPPL	2013-04-17
7290	SUPPL	2012-09-24
29643	SUPPL	2011-12-08
24288	ORIG	2009-12-30
22001	ORIG	2009-12-30
7289	ORIG	2009-05-27