Application 020714

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTROL	NICOTINE	INHALANT;ORAL	4MG/CARTRIDGE	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020714-001	NICOTROL	NICOTINE	4MG/CARTRIDGE	INHALANT / ORAL		RLD	1997-05-02

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 2 · 42 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	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Transdermal System step 3	NICOTINE	AmerisourceBergen Drug Corporation	e51d2c09-a20f-eb9b-e3e4-013f3e488ab3	2026-07-01	Warnings	Name fallback generic name: NICOTINE
nicotine	NICOTINE	H E B	bfe954a2-c078-4a63-a3bb-f9ef7d8806f7	2026-06-25	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	H E B	da70bf12-4454-40ac-8cfd-8b7697496d55	2026-06-19	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	H E B	08d448f6-7cf1-4725-978a-01dfe7dc07c8	2026-06-18	Warnings	Name fallback generic name: NICOTINE
Nicotine Stop Smoking AID	NICOTINE	Guangxi Keyun E-commerce Co., Ltd.	4d724a5a-425e-e441-e063-6294a90a761e	2026-06-03	Warnings	Name fallback generic name: NICOTINE
Nicotine Stop Smoking AID	NICOTINE	Guangxi Keyun E-commerce Co., Ltd.	4d70b8f1-31ab-4aa1-e063-6294a90a13a9	2026-06-03	Warnings	Name fallback generic name: NICOTINE
Nicotine Stop Smoking AID	NICOTINE	Guangxi Keyun E-commerce Co., Ltd.	4d7219e6-17a9-b7d9-e063-6394a90a465e	2026-06-03	Warnings	Name fallback generic name: NICOTINE
Nicotine Patch	NICOTINE	Guangzhou Yunzhen Trading Co., Ltd.	5237a533-e87f-87af-e063-6294a90a551a	2026-05-19	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	Rugby Laboratories	ae406389-0f83-d5c8-bd2f-56075e57453a	2026-03-25	Warnings	Name fallback generic name: NICOTINE
Nicotine Transdermal System step 3	NICOTINE	CARDINAL HEALTH 110, LLC. DBA LEADER	dbbed17b-8ad3-05fb-fb63-03fbb75eae05	2026-03-18	Warnings	Name fallback generic name: NICOTINE
NICOTINE TRANSDERMAL SYSTEM	NICOTINE	A-S Medication Solutions	cfb56e3e-ac5d-4086-a5d3-23080844b3e1	2026-03-13	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	H E B	85e3a322-e1a2-4f8e-a616-b279ad1bcefe	2026-03-03	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	H E B	be4a13e4-9938-4223-bcc1-4f5d96972813	2026-03-03	Warnings	Name fallback generic name: NICOTINE
nicotine polacrilex	NICOTINE	H E B	d1f1453d-75a8-4c54-a28a-fb631db54ba4	2026-02-03	Warnings	Name fallback generic name: NICOTINE
Sielkin QUIT SMOKING NICOTINE PATCHES 14mg	NICOTINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	29b55f67-503f-cf96-e063-6294a90a5f65	2026-01-28	Warnings	Name fallback generic name: NICOTINE
Sielkin QUIT SMOKING NICOTINE PATCHES	NICOTINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	2969f3cc-8e45-f93d-e063-6294a90a93ad	2026-01-28	Warnings	Name fallback generic name: NICOTINE
Sielkin QUIT SMOKING NICOTINE PATCHES 21mg	NICOTINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	29b6287b-3ce3-e446-e063-6294a90a163b	2026-01-27	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system	NICOTINE	Wal-Mart Stores Inc	aefd30c4-35d5-425e-855c-327a7c436188	2026-01-26	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	Meijer, Inc.	78b85047-b412-44fa-91e1-a1c891d47876	2026-01-22	Warnings	Name fallback generic name: NICOTINE
Nicotine Stop Smoking AID	NICOTINE	Guangxi Keyun E-commerce Co., Ltd.	45a7e1cf-7182-6ec3-e063-6394a90ae441	2025-12-11	Warnings	Name fallback generic name: NICOTINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-5400	Nicotrol	nicotine	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5400	Nicotrol	nicotine	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5400	Nicotrol	nicotine	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78557	SUPPL	2024-05-24
78551	SUPPL	2024-05-24
59893	SUPPL	2019-09-03
59881	SUPPL	2019-08-30
25615	SUPPL	2009-07-08
25614	SUPPL	2004-07-21
25613	SUPPL	2003-11-25
41606	ORIG	2003-08-08
3181	SUPPL	2002-09-08