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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078967-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`cb3db0bc1861…`

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 3 of 26 · 508 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Habitrol Lozenge Cherry	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5a464242-7d63-141e-808e-c41676cf4b78	2026-07-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine coated	NICOTINE POLACRILEX	Publix Super Markets Inc	8cb5577b-48c0-47f8-8979-0ab54d713045	2026-07-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	6b0342dd-120f-a16e-098a-dc45b14d3d3a	2026-07-09	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	353221c6-96c7-4c4b-a114-03e71d2114f8	2026-07-07	Warnings	Name fallback generic name: NICOTINE POLACRILEX
DG HEALTH NICOTINE	NICOTINE POLACRILEX	Dolgencorp Inc	b44f0525-abf6-461d-ae15-40d162021eaa	2026-07-01	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	174c342d-898e-4d16-a688-5184a1ae409f	2026-06-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	03d9708a-923c-4fd3-ac3d-6ab4a4d8a804	2026-06-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
topcare nicotine	NICOTINE POLACRILEX	Topco Associates LLC	c3c52b83-fdbe-4999-b982-37c63462eb7c	2026-06-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	189c13db-b4b7-4534-ae3c-1c52bb879e2b	2026-06-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	f0f79275-c27a-4d35-a79a-53b0905c3761	2026-06-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	768e3f3d-d867-4574-8a5d-07572e2e4a04	2026-06-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	H E B	9bf10dfc-c6df-4cc9-ba79-2dcf874a2904	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	b8cbb6a7-aeb4-48f3-a0ed-7ad803021752	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	H E B	a1f36614-539f-45db-aad4-1b300c60bf43	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	H E B	55defc7f-f91d-46eb-8558-2ab1b69ec6a1	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Kroger Company	35f45900-af2e-4b74-9772-8beb55236457	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	21014e98-2c7c-4cc6-8595-a717910710a4	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	060ef0cb-52ef-47b1-bcba-856e443d18a9	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Kroger Company	e4a7cf2a-5fd9-4390-8517-e532900ff81c	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	fd9ce0e2-b159-4e0d-a76e-7223d36810fb	2026-06-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX

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