Application 078967

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
A078967-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG 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	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078967-001	NICOTINE POLACRILEX	EQ 2MG 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 23 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicorette Fruit Chill	NICOTINE POLACRILEX	Haleon US Holdings LLC	a0206139-59c6-44c3-963c-8cb5f2d69075	2024-07-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2	2024-07-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	114418c4-6f39-46ce-912c-ac3687b7b75e	2024-07-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	c505dde1-2647-4c7b-99f5-9865e7c78e43	2024-06-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
good sense nicotine	NICOTINE POLACRILEX	L. Perrigo Company	ee345181-4999-4948-9589-7d70d61885ad	2024-06-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
good sense nicotine	NICOTINE POLACRILEX	A-S Medication Solutions	af4323b6-5240-4697-992a-512c4d098340	2024-05-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	CVS Pharmacy	a7348e93-bc5d-48d8-b2a4-daf921343d44	2024-05-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up cherry nicotine	NICOTINE POLACRILEX	Target Corporation	85d82812-9f90-401f-8a2c-729cbfdf4c78	2024-03-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up mint nicotine	NICOTINE POLACRILEX	Target Corporation	740833d6-5406-4609-9d14-bd5c9072fe9a	2024-03-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up mint nicotine	NICOTINE POLACRILEX	Target Corporation	cf7e3e9d-ec46-49de-b760-63d89c67823a	2024-03-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	991704ed-781a-489b-8b56-0b558e8fc385	2024-03-21	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	fdee1637-8049-4bc5-b196-b6d854c9f9f3	2024-03-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreens	446c857f-2380-4019-9a82-9fb9ee060d08	2024-02-21	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up nicotine	NICOTINE POLACRILEX	Target Corporation	65a612e8-18d3-49fd-844f-4ccd0210acd3	2024-02-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up nicotine	NICOTINE POLACRILEX	Target Corporation	c0c667b8-7384-4970-8f27-f108192c3256	2024-02-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreens	19bd0eb4-0cd6-4979-bef6-eedbd4d5de88	2024-02-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	A-S Medication Solutions	d84f27e4-c63b-4d04-9e65-bdb1a3594f92	2024-01-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicorette 4mg Fruit Chill Gum, Lil Drug Store	NICOTINE POLACRILEX	Lil' Drug Store Products, Inc.	0e85dcfa-d9e1-5fbb-e063-6394a90aeae6	2024-01-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicorette 4mg White Ice Mint Gum, Lil Drug Store	NICOTINE POLACRILEX	Lil' Drug Store Products, Inc.	0e894f4f-2d41-24c2-e063-6294a90ae26c	2024-01-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicorette 4mg Cinnamon Surge	NICOTINE POLACRILEX	Lil' Drug Store products, Inc.	0e74e9fd-f79a-ffea-e063-6394a90a721e	2024-01-08	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
11673-293	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current