Application 019983

Type: NDA
Sponsor: AVEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROSTEP	NICOTINE	Film, Extended Release; Transdermal	11MG/24HR	No	No
002	PROSTEP	NICOTINE	Film, Extended Release; Transdermal	22MG/24HR	No	No
003	PROSTEP	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	11MG/24HR	No	No
004	PROSTEP	NICOTINE	FILM, EXTENDED RELEASE;TRANSDERMAL	22MG/24HR	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019983-003	PROSTEP	NICOTINE	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL			1998-12-23
N019983-004	PROSTEP	NICOTINE	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL			1998-12-23

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`74a2ff9319b5…`

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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUHIO Nicotine Patch	NICOTINE	Guangxi Keyun E-commerce Co., Ltd.	45a53cd6-3e3f-697a-e063-6394a90a6c83	2025-12-10	Warnings	Name fallback generic name: NICOTINE
NWRB Nicotine Transdermal Patch	NICOTINE	Dongkou County Hecheng Network Technology Co., Ltd.	44f3e697-1859-dab0-e063-6294a90a4517	2025-12-02	Warnings	Name fallback generic name: NICOTINE
STPSMK QUIT SMOKING NICOTINE PATCHES	NICOTINE	Guangzhou Ouruisi Biotechnology Co., Ltd	43c1b4e9-39ee-d398-e063-6394a90a71f0	2025-11-16	Warnings	Name fallback generic name: NICOTINE
Medline	NICOTINE	Medline Industries, LP	e11a4b7e-6f1f-24db-e053-2a95a90a0d09	2025-11-04	Warnings	Name fallback generic name: NICOTINE
RBUGR QUIT SMOKING Nicotine Patches	NICOTINE	Nanjing Ludejin Corporation Management Co., Ltd	412d42c7-d382-20cc-e063-6294a90ae384	2025-10-15	Warnings	Name fallback generic name: NICOTINE
quit smoking patches	NICOTINE	Henan Jiugao Cross-border Ecommerce Co., Ltd.	40b1c2ab-a14d-0884-e063-6294a90a6ecb	2025-10-08	Warnings	Name fallback generic name: NICOTINE
NICOTINUM	NICOTINE	Boiron	3b8cb10e-6fbb-c542-e063-6294a90a967a	2025-08-04		Name fallback generic name: NICOTINE
Nicotine	NICOTINE	Strategic Sourcing Services LLC	a08022ff-e412-47f9-8132-318f55528c5c	2025-07-30	Warnings	Name fallback generic name: NICOTINE
NICODERM CQ	NICOTINE	Haleon US Holdings LLC	93b2d1b9-83c1-40b5-b6af-90c38c8d6cef	2025-07-14	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system	NICOTINE	Sam's West Inc	cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7	2025-06-10	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system	NICOTINE	Target Corporation	f8d6bf61-6d66-4651-8145-c4cb1d5e443f	2025-06-10	Warnings	Name fallback generic name: NICOTINE
Nicotine Transdermal System	NICOTINE	EXELAN PHARMACEUTICALS, INC.	5aeb4f5c-7cc4-4532-b76e-53bdee8e7220	2025-06-01	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	A-S Medication Solutions	13aa171e-7425-47fc-b618-7759840f0618	2025-05-30	Warnings	Name fallback generic name: NICOTINE
Nicotrol	NICOTINE	Pharmacia & Upjohn Company LLC	acb7d02d-249b-4645-ac1b-8ff9a56dd244	2025-05-29	Warnings, Adverse reactions	Name fallback generic name: NICOTINE
QUIT SMOKING Proven Patches	NICOTINE	Jiashen International Trade Limited	35570155-c769-dc4c-e063-6394a90a019d	2025-05-17	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	Golden State Medical Supply, Inc.	7c83d507-7e8d-496c-bb9d-63abfa25c7a7	2025-04-17	Warnings	Name fallback generic name: NICOTINE
SEFUDUN QUIT SMOKING NICOTINE PATCHES	NICOTINE	Shenzhen Shandian Jingling Technology Co., Ltd.	314e6f25-8fd0-38ba-e063-6294a90aca8b	2025-03-27	Warnings	Name fallback generic name: NICOTINE
Nicorette Fruit Chill nicotine polacrilex	NICOTINE	Lil' Drug Store Products, Inc.	01db011d-924c-40e4-bd5d-44eb267b8de1	2024-12-30	Warnings	Name fallback generic name: NICOTINE
Nicorette White Mint nicotine polacrilex	NICOTINE	Lil' Drug Store Products, Inc.	4aec3330-411e-415f-a505-3ab7fa7295bb	2024-12-30	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	CVS Pharmacy	d51d5224-f5bf-2510-1fa0-c4bb454f8160	2024-12-01	Warnings	Name fallback generic name: NICOTINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1885	SUPPL	2002-10-04
12116	SUPPL	2002-01-18
1884	SUPPL	2002-01-18
41115	SUPPL	1998-12-23
20444	SUPPL	1998-12-23
1883	SUPPL	1998-12-23
1882	SUPPL	1998-12-23