Application 020385

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTROL	NICOTINE	SPRAY, METERED;NASAL	0.5MG/SPRAY	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
N020385-001	NICOTROL	NICOTINE	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	1996-03-22

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	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotrol	NICOTINE	Pharmacia & Upjohn Company LLC	acb7d02d-249b-4645-ac1b-8ff9a56dd244	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020385 application number: NDA020385 ndc (product): 0009-5401

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-5401	Nicotrol	nicotine	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5401	Nicotrol	nicotine	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5401	Nicotrol	nicotine	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5401	Nicotrol	nicotine	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5401	Nicotrol	nicotine	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78556	SUPPL	2024-05-24
78550	SUPPL	2024-05-24
59892	SUPPL	2019-09-03
59882	SUPPL	2019-08-30
34584	SUPPL	2010-07-01
24879	SUPPL	2010-07-01
2439	SUPPL	2004-07-21
2438	SUPPL	2003-11-25
24878	SUPPL	2002-09-08