Application 020165

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	NICODERM CQ	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	21MG/24HR	Yes	Yes
005	NICODERM CQ	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	14MG/24HR	Yes	No
006	NICODERM CQ	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	7MG/24HR	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020165-004	NICODERM CQ	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02
N020165-005	NICODERM CQ	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02
N020165-006	NICODERM CQ	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020165-004	9205059	2019-12-15		Drug product	2016-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-004	8663680	2020-02-13		Drug product	2014-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-004	8999379	2020-02-13	U-1686		2015-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	9205059	2019-12-15		Drug product	2016-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	8663680	2020-02-13		Drug product	2014-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	8999379	2020-02-13	U-1686		2015-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	8075911	2021-05-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	9205059	2019-12-15		Drug product	2016-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	8663680	2020-02-13		Drug product	2014-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	8999379	2020-02-13	U-1686		2015-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	8075911	2021-05-22		Drug product		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020165-005	8075911	2021-05-22		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020165-006	8075911	2021-05-22		Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020165-005	8075911	2021-05-22		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020165-006	8075911	2021-05-22		Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020165-005	8075911	2021-05-22		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020165-006	8075911	2021-05-22		Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020165-004	8663680	2020-02-13		Drug product	2014-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-004	8999379	2020-02-13	U-1686		2015-05-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-005	8663680	2020-02-13		Drug product	2014-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-005	8999379	2020-02-13	U-1686		2015-05-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-005	8075911	2021-05-22		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-006	8663680	2020-02-13		Drug product	2014-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-006	8999379	2020-02-13	U-1686		2015-05-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-006	8075911	2021-05-22		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020165-004	8663680	2020-02-13		Drug product	2014-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-004	8999379	2020-02-13	U-1686		2015-05-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-005	8663680	2020-02-13		Drug product	2014-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-005	8999379	2020-02-13	U-1686		2015-05-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-005	8075911	2021-05-22		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-006	8663680	2020-02-13		Drug product	2014-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-006	8999379	2020-02-13	U-1686		2015-05-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-006	8075911	2021-05-22		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020165-004	9205059	2019-12-15		Drug product	2016-01-06	`3f01610625f2…`

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
Nicotine transdermal system	NICOTINE	Wal-Mart Stores Inc	aefd30c4-35d5-425e-855c-327a7c436188	2026-01-26	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165 ndc (product): 49035-196 ndc (product): 49035-195 ndc (product): 49035-194
NICODERM CQ	NICOTINE	Haleon US Holdings LLC	93b2d1b9-83c1-40b5-b6af-90c38c8d6cef	2025-07-14	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165 ndc (product): 0135-0195 ndc (product): 0135-0196 ndc (product): 0135-0194
Nicotine transdermal system	NICOTINE	Sam's West Inc	cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7	2025-06-10	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165 ndc (product): 68196-194
Nicotine transdermal system	NICOTINE	Target Corporation	f8d6bf61-6d66-4651-8145-c4cb1d5e443f	2025-06-10	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165 ndc (product): 11673-195 ndc (product): 11673-194 ndc (product): 11673-196

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0194	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0194	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0194	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0195	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0195	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0195	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0196	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0196	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0196	NICODERM	nicotine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
11673-194	NICOTINE	nicotine	Target Corporation	NDA	Current
11673-194	NICOTINE	nicotine	Target Corporation	NDA	Current
11673-194	Nicotine	nicotine	Target Corporation	NDA	Current
11673-195	NICOTINE	nicotine	Target Corporation	NDA	Current
11673-195	NICOTINE	nicotine	Target Corporation	NDA	Current
11673-195	Nicotine	nicotine	Target Corporation	NDA	Current
11673-196	NICOTINE	nicotine	Target Corporation	NDA	Current
11673-196	NICOTINE	nicotine	Target Corporation	NDA	Current
11673-196	Nicotine	nicotine	Target Corporation	NDA	Current
49035-194	NICOTINE	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-194	Nicotine	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-194	NICOTINE	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-195	NICOTINE	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-195	Nicotine	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-195	NICOTINE	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-196	NICOTINE	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-196	Nicotine	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
49035-196	NICOTINE	nicotine	Wal-Mart Stores Inc	NDA AUTHORIZED GENERIC	Current
68196-194	Nicotine	nicotine	Sam's West Inc	NDA	Current
68196-194	Nicotine	nicotine	Sam's West Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80889	SUPPL	2025-01-21
80888	SUPPL	2025-01-21
70408	SUPPL	2022-03-07
70407	SUPPL	2022-03-07
21255	SUPPL	2016-05-06
12295	SUPPL	2016-05-06
12294	SUPPL	2015-11-25
2132	SUPPL	2015-10-13
34338	SUPPL	2015-08-10
21254	SUPPL	2015-08-10
12293	SUPPL	2015-02-17
2131	SUPPL	2015-02-05
12292	SUPPL	2014-05-06
21252	SUPPL	2014-05-01
34337	SUPPL	2013-11-19
21253	SUPPL	2013-11-06
21251	SUPPL	2012-09-24
20516	SUPPL	2007-11-19
21250	SUPPL	2007-04-20
12291	SUPPL	2007-04-19
2130	SUPPL	2006-09-20
34336	SUPPL	2006-09-18
2129	SUPPL	2002-08-13