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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine transdermal system step 3	NICOTINE	Strategic Sourcing Services LLC	6c0b5b5c-cc76-6e48-c364-4db0e081557d	2024-11-09	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	Rite Aid Corporation	d2e32434-ec58-943e-dbeb-8e7331531595	2024-07-26	Warnings	Name fallback generic name: NICOTINE
NICOTINE TRANSDERMAL	NICOTINE	Rite Aid Corporation	ae6027da-5c96-ed47-e1ae-e900fc0f72ce	2024-07-26	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	The Kroger Co.	13cdd780-4196-685b-3cab-f9694a327618	2024-07-25	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 2	NICOTINE	Chain Drug Marketing Association INC	df1348cb-0d15-7e4b-921c-d8764c858e66	2024-07-25	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system	NICOTINE	Dr. Reddys Laboratories Inc.	e2391b29-9bac-fc09-f2a5-a3370bc4e2c3	2024-07-25	Warnings	Name fallback generic name: NICOTINE
nicotine transdermal system	NICOTINE	Dr. Reddy's Laboratories Inc.	b9946e3c-80c9-3076-7c32-e2988ac07048	2024-07-25	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 1	NICOTINE	DOLGENCORP, LLC	81e55db2-897e-e567-5743-63179783291a	2024-07-25	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	Walgreens Company	de471db4-b332-0490-198d-d35480272874	2024-07-25	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	Dr. Reddy's Laboratories Inc.	3a68eb70-0548-fa6f-8b1c-375e8799f24f	2024-07-24	Warnings	Name fallback generic name: NICOTINE
Nicotine	NICOTINE	Rugby Laboratories	2dd4cbda-5c46-4655-b69d-21b7d2e912cf	2024-06-05	Warnings	Name fallback generic name: NICOTINE
Nicotinum	NICOTINE	Boiron	7f6f83a5-f680-6ce2-e053-2991aa0ab8fc	2023-11-14		Name fallback generic name: NICOTINE
Kirkland Signature Nicotine	NICOTINE	Costco Wholesale Company	0888a974-a8ba-4cb3-996f-c8abfcb90a6f	2023-06-01	Warnings	Name fallback generic name: NICOTINE
Kirkland Signature Nicotine	NICOTINE	Costco Wholesale Company	33098a72-9146-4547-9d0b-ff28c8c80030	2023-05-26	Warnings	Name fallback generic name: NICOTINE
Nicotine transdermal system step 3	NICOTINE	A-S Medication Solutions	798a66fa-25d8-4713-b25f-56875431e37d	2023-03-02	Warnings	Name fallback generic name: NICOTINE
nicotine	NICOTINE	H E B	98633912-74d8-49db-a03e-4a3f882297ac	2019-04-17	Warnings	Name fallback generic name: NICOTINE
nicotine	NICOTINE	H E B	691f3f8d-7242-4855-b80b-4d5af0490b37	2019-04-16	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