Application 078325

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
A078325-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2006-10-30

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	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	049d2c75-9b7f-4248-81e9-e2973a4cab5d	2026-03-03	Warnings	Exact identifier application applno (ANDA): 078325 application number: ANDA078325 ndc (product): 49035-206

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0206	good sense nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-0206	good sense nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-0761	basic care nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-0761	basic care nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-0761	basic care nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0904-5736	Nicorelief	Nicotine Polacrilex	Major Pharmaceuticals	ANDA	Current
11673-206	up and up nicotine polacrilex	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-206	up and up nicotine polacrilex	Nicotine Polacrilex	Target Corporation	ANDA	Current
17856-5736	Nicorelief	Nicotine Polacrilex	Atlantic Biologicals Corps	ANDA	Current
24385-594	Good Neighbor Pharmacy Nicotine	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
24385-594	Good Neighbor Pharmacy Nicotine	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
30142-206	nicotine	Nicotine Polacrilex	Kroger Company	ANDA	Current
36800-206	Topcare Nicotine	Nicotine Polacrilex	Topco Associates LLC	ANDA	Current
36800-206	Topcare Nicotine	Nicotine Polacrilex	Topco Associates LLC	ANDA	Current
37808-206	In Control Nicotine	Nicotine Polacrilex	H E B	ANDA	Current
37808-206	In Control Nicotine	Nicotine Polacrilex	H E B	ANDA	Current
37808-911	Nicotine	nicotine	H E B	ANDA	Current
37808-911	Nicotine	nicotine	H E B	ANDA	Current
41250-206	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-206	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-206	nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
45802-206	Nicotine Polacrilex	Nicotine Polacrilex	Perrigo New York Inc	ANDA	Current
45802-206	Nicotine Polacrilex	Nicotine Polacrilex	Perrigo New York Inc	ANDA	Current
46122-171	Good Neighbor Pharmacy Nicotine	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
46122-171	Good Neighbor Pharmacy Nicotine	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
46122-171	Good Neighbor Pharmacy Nicotine	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
49035-206	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-206	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-206	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49348-691	Sunmark Nicotine	Nicotine Polacrilex	Strategic Sourcing Services LLC	ANDA	Current
49348-691	Sunmark Nicotine	Nicotine Polacrilex	Strategic Sourcing Services LLC	ANDA	Current
49348-691	Sunmark Nicotine	Nicotine Polacrilex	Strategic Sourcing Services LLC	ANDA	Current
49348-691	Sunmark Nicotine	Nicotine Polacrilex	McKesson	ANDA	Current
50090-1145	Nicorelief	Nicotine Polacrilex	A-S Medication Solutions	ANDA	Current
62011-0047	health mart nicotine	Nicotine Polacrilex	Strategic Sourcing Services LLC	ANDA	Current
62011-0047	health mart nicotine	Nicotine Polacrilex	Strategic Sourcing Services LLC	ANDA	Current
62011-0047	health mart nicotine	Nicotine Polacrilex	McKesson	ANDA	Current
62011-0047	health mart nicotine	Nicotine Polacrilex	Strategic Sourcing Services LLC	ANDA	Current
64725-0691	Sunmark Nicotine	Nicotine Polacrilex	TYA Pharmaceuticals	ANDA	Current
72288-206	basic care nicotine	Nicotine Polacrilex	Amazon.com Services LLC	ANDA	Current
72288-206	basic care nicotine	Nicotine Polacrilex	Amazon.com Services LLC	ANDA	Current