Application 091349

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 2MG BASE	No	No

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

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
A091349-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2011-07-20

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 · 43 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	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`f41ea6bd6efb…`

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 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Walgreens	97ce52b1-d98e-4216-99c2-7e341c8fec43	2026-08-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	4ab742f2-2599-4d9f-83c5-9338d66ad6cf	2026-08-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Cardinal Health 107, LLC	ebab2c3a-4fda-40d6-8f54-972e1c6ee69a	2026-08-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE MINI	NICOTINE POLACRILEX	Amazon.com Services LLC	b957f757-2b34-49b2-a68b-a7bc9e8dd8b2	2026-08-21	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	Walgreen Company	5dd116ea-d031-439c-b06c-2f77230bc446	2026-08-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	e40a534e-8083-454d-9667-826bfbac397c	2026-08-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	bc1b6b41-d069-470e-90ca-a441ab97f96a	2026-08-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	WALMART INC. (see also Equate)	286e2768-ad98-43be-a3be-a2db0370f50f	2026-08-12	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	WALMART INC. (see also Equate)	b49546cd-6cc4-422c-9a72-3a1faf2abcd3	2026-08-12	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	a33b6ed6-2c75-4bab-98e5-a7f8bea21926	2026-08-12	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	9ba85e0a-bcb7-4803-8d21-0eb93768cb3a	2026-08-07	Warnings	Name fallback generic name: NICOTINE POLACRILEX
QUITINE NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	1f93571c-4bd2-4272-ab9f-240b7c8a024b	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	30e00817-75ff-43db-901c-c180e6730901	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Quitine Nicotine	NICOTINE POLACRILEX	QUITINE LLC	4cc32b8c-6316-4d4b-8fa9-ef640464ca69	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE GUM	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	4e88dab4-8e13-f074-e063-6394a90a3908	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Oneoo Nicotine Gum (Mint)	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	54b1329b-b422-29a5-e063-6294a90a8780	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	P & L Development, LLC	3623455a-3f00-41d3-b17e-86a016da7047	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Quitine Nicotine	NICOTINE POLACRILEX	QUITINE LLC	10e3e1ac-2f78-4ce4-8f38-a283fac99660	2026-08-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecd78195-2df2-401d-b590-2c1cb764df5c	2026-08-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecf97d6b-6ca7-48c1-8c37-029421689cc1	2026-08-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0365	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0365	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0365	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0365	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0365	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0365	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
11673-365	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-365	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-365	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-365	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11822-0365	nicotine gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-0365	nicotine gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-0365	nicotine gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-0365	nicotine gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
41250-365	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-365	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-365	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-365	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-365	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
42884-365	Zonnic Nicotine Polacrilex	Nicotine Polacrilex	Niconovum USA Inc.	ANDA	Current
49035-365	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-365	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-365	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
59779-637	nicotine	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
68196-365	members mark nicotine	Nicotine Polacrilex	Sam's West Inc	ANDA	Current
68196-365	members mark nicotine	Nicotine Polacrilex	Sam's West Inc	ANDA	Current