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 20 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	a275ff04-4078-4783-932b-dde9aee04682	2025-08-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	63fce25d-457f-4048-86a4-1805f603936c	2025-08-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	9f77adad-4b67-48c8-9ad4-24bccdea3ae2	2025-08-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	47561b44-572e-4ca0-b91c-db0706131363	2025-08-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Maxi Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	1472b0a3-5ff1-44e7-8748-a3b1a5e55196	2025-08-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	Rite Aid Corporation	876b80a3-3ea8-4821-9716-c18e24502822	2025-08-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	H E B	f3e395db-61e8-43cb-bf95-8cacd17f5d9a	2025-08-13	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Walgreen Company	6c5d786b-8b5a-460a-ae67-c11de9858ad4	2025-08-10	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreen Company	af8fadbb-25a7-4ab7-a665-808e4b41978a	2025-08-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Rite Aid Corporation	63a433aa-8c73-47a0-be64-8708f8478fff	2025-08-07	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicorette Peppermint	NICOTINE POLACRILEX	Haleon US Holdings LLC	990a4a65-d573-46a9-889d-60afb0018944	2025-07-31	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Bryant Ranch Prepack	c2627853-945b-42d8-8351-39028e513d77	2025-07-29	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Bryant Ranch Prepack	16ece78d-c66e-43c1-953a-f774797ae097	2025-07-29	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	a18dde9f-700f-4572-a6aa-577dbacdf314	2025-07-29	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Lucy Goods, Inc.	20aa42c6-14e3-46c5-ba0f-fef217e0b1c2	2025-07-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Lucy Goods, Inc.	bca1c2ab-2263-429d-9f09-f848dd3d826e	2025-07-21	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	150faf42-491f-403b-869b-48edd431d1cc	2025-07-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Maxi Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	7c2e0872-75f6-4c4f-afff-3579375708de	2025-07-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	be17cbe9-43bb-424e-9d91-fba4f02691bb	2025-07-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	76034dd1-361c-442c-92aa-8fa7cf47a507	2025-07-18	Warnings	Name fallback brand name: Nicotine Polacrilex 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