Application 078546

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 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
A078546-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2007-05-24

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	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`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 1 of 1 · 6 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	b8cbb6a7-aeb4-48f3-a0ed-7ad803021752	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546 ndc (product): 0113-0854
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	59ba5cba-be1e-4708-a9ab-01f43543bb5b	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546 ndc (product): 41250-854
Care One Nicotine	NICOTINE POLACRILEX	American Sales Company	78cf8b14-cdad-464c-afb5-9fc49ebc3921	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546 ndc (product): 41520-854
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	2026-05-20	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	0f1b3cc6-98df-4e34-91f3-dc251fe170f8	2026-04-28	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	54c1a1d5-f7b4-4109-8887-02dc10bfd593	2025-09-16	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546 ndc (product): 49035-854

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0854	Good Sense Nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-0854	Good Sense Nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-0854	Good Sense Nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-0854	Good Sense Nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0363-0854	Nicotine	Nicotine polacrilex	Walgreen Company	ANDA	Current
0363-0854	Nicotine	Nicotine polacrilex	Walgreen Company	ANDA	Current
11673-854	Up and Up Nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current
11822-0854	Nicotine	Nicotine polacrilex	Rite Aid Corporation	ANDA	Current
11822-0854	Nicotine	Nicotine polacrilex	Rite Aid Corporation	ANDA	Current
11822-0854	Nicotine	Nicotine polacrilex	Rite Aid Corporation	ANDA	Current
21130-168	signature care nicotine	Nicotine polacrilex	Safeway	ANDA	Current
30142-854	Nicotine	Nicotine polacrilex	Kroger Company	ANDA	Current
30142-854	Nicotine	Nicotine polacrilex	Kroger Company	ANDA	Current
36800-854	Topcare nicotine	Nicotine polacrilex	Topco Associates LLC	ANDA	Current
36800-854	Topcare nicotine	Nicotine polacrilex	Topco Associates LLC	ANDA	Current
37808-854	In Control Nicotine	Nicotine polacrilex	H E B	ANDA	Current
41250-854	Nicotine	Nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-854	Nicotine	Nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41520-854	Care One Nicotine	Nicotine polacrilex	American Sales Company	ANDA	Current
41520-854	Care One Nicotine	Nicotine polacrilex	American Sales Company	ANDA	Current
41520-854	Care One Nicotine	Nicotine polacrilex	American Sales Company	ANDA	Current
42884-854	Zonnic Nicotine	Nicotine polacrilex	Niconovum USA Inc.	ANDA	Current
46122-666	good neighbor pharmacy nicotine	Nicotine polacrilex	Amerisource Bergen	ANDA	Current
46122-666	good neighbor pharmacy nicotine	Nicotine polacrilex	Amerisource Bergen	ANDA	Current
49035-854	Equate Nicotine	Nicotine polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-854	Equate Nicotine	Nicotine polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-854	Equate Nicotine	Nicotine polacrilex	Wal-Mart Stores Inc	ANDA	Current
59779-854	nicotine	Nicotine polacrilex	CVS Pharmacy	ANDA	Current
62011-0426	health mart nicotine polacrilex	Nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current
62011-0426	health mart nicotine polacrilex	Nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current
62011-0426	health mart nicotine polacrilex	Nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current
68196-004	members mark nicotine	Nicotine polacrilex	Sam's West Inc	ANDA	Current
70677-0086	sunmark nicotine	Nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current
70677-0086	sunmark nicotine	Nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current
70677-0086	sunmark nicotine	Nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current