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 1.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019983-003	PROSTEP	11MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019983-004	PROSTEP	22MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1998-12-23	`782e0a99824c…`

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 · 59 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 Oral Pouch	NICOTINE	Guangzhou Shuimu Jiahe Trading Co., Ltd.	4c853456-51ef-abf3-e063-6394a90aa4ce	2026-04-24	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

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