Application 078968

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 4MG 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
A078968-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2008-04-23

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 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	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`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 19 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	477689fc-688a-4c76-8c02-35a7a15adc5e	2025-11-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	27c579b5-1021-4551-9680-bf8978e1d9b4	2025-11-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	17b00f7a-50ac-46ac-b172-6c6c35e9ca7b	2025-11-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
members mark Nicotine	NICOTINE POLACRILEX	Sam's West Inc	c31c30b9-7431-4b90-b011-f34e499df192	2025-11-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Walgreen Company	b1154b04-b3a6-4af9-a933-486c5501d46e	2025-11-11	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	794606a1-12e7-405e-81b2-33ce3fd61832	2025-10-21	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	Safeway	97ad8d6d-813f-4c59-93a1-184c913162ea	2025-10-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Padagis Israel Pharmaceuticals Ltd	8d4dfba9-1571-4128-9cdc-47cdce04e3e4	2025-10-07	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	69159b7c-206e-457d-88e2-f7ff0a12a793	2025-10-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine mini	NICOTINE POLACRILEX	Walgreen Company	33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd	2025-10-02	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	A-S Medication Solutions	7b70162e-0087-466f-9b8b-8289b6e90e39	2025-09-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
berkley and jensen nicotine polacrilex	NICOTINE POLACRILEX	BJWC	b586ce1c-77cd-497c-b22c-8c97f54583ba	2025-09-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
members mark nicotine	NICOTINE POLACRILEX	Sam's West Inc	d185b5e7-9bb1-4d16-b146-1fbfba874053	2025-09-16	Warnings	Name fallback generic name: NICOTINE POLACRILEX
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	7b1b5f6e-c5ee-48fc-85ee-2e11c30213e4	2025-09-16	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Kroger Company	0b1874bd-f908-485a-b045-7d0050be7bb2	2025-09-13	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	03b27d95-f2cb-43d4-9bc3-55ea66fadb0d	2025-09-13	Warnings	Name fallback generic name: NICOTINE POLACRILEX
mini nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	426b2f92-561d-476b-959c-cdd0fa37be56	2025-09-12	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	04f2b325-2243-4c6f-880c-45f2543091da	2025-09-12	Warnings	Name fallback generic name: NICOTINE POLACRILEX
stop smoking aid	NICOTINE POLACRILEX	Publix Super Markets Inc	63d4ceab-2474-49cd-bb4f-63728eee6ac5	2025-09-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	237471f8-ce0f-423b-993f-b4380fd890ff	2025-09-02	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11673-652	up and up nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current