Application 021330

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
N021330-001	NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL		RLD	2002-10-31
N021330-002	NICORETTE	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL		RLD, RS	2002-10-31

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	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`3a93d1ddd44b…`

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	NICOTINE POLACRILEX	Haleon US Holdings LLC	f350e050-2173-43e0-8738-848382ce0700	2025-06-04	Warnings	Exact identifier application applno (NDA): 021330 application number: NDA021330 ndc (product): 0135-0626 ndc (product): 0135-0625
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	991704ed-781a-489b-8b56-0b558e8fc385	2024-03-21	Warnings	Exact identifier application applno (NDA): 021330 application number: NDA021330 ndc (product): 0135-0510 ndc (product): 0135-0511

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0510	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0510	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0511	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0511	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0625	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0625	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0625	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0625	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0626	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0626	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0626	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0626	NICORETTE	nicotine polacrilex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79564	SUPPL	2024-09-09
79563	SUPPL	2024-09-09
69337	SUPPL	2021-11-17
69291	SUPPL	2021-11-10
62852	SUPPL	2020-05-08
58835	SUPPL	2019-05-22
58834	SUPPL	2019-05-22
52737	SUPPL	2018-02-27
52735	SUPPL	2018-02-27
52734	SUPPL	2018-02-27
52733	SUPPL	2018-02-27
48855	SUPPL	2017-06-28
36669	SUPPL	2015-10-22
5057	SUPPL	2015-10-02
15204	SUPPL	2015-08-10
5058	SUPPL	2015-08-10
27497	SUPPL	2015-05-20
15203	SUPPL	2015-05-20
36668	SUPPL	2014-08-25
5056	SUPPL	2014-08-15
15202	SUPPL	2013-11-07
5055	SUPPL	2013-10-29
27496	SUPPL	2013-08-08
27495	SUPPL	2012-05-29
27494	SUPPL	2010-08-31
5054	SUPPL	2010-01-15
5053	SUPPL	2008-05-28
5052	SUPPL	2006-09-18
15200	SUPPL	2006-09-15
36667	SUPPL	2005-11-30
5051	SUPPL	2005-11-30
27493	SUPPL	2005-11-01
15199	SUPPL	2005-11-01
21602	ORIG	2004-06-29
15198	SUPPL	2004-03-03
5050	SUPPL	2004-02-27
5049	ORIG	2002-10-31