Application 204794

Type: ANDA
Sponsor: P AND L

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
A204794-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2016-05-10

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	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex Coated Ice Mint	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	2026-04-13	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794 ndc (product): 70000-0348
Nicotine Polacrilex	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	9c115cd5-1952-4f1e-8e88-27f2c528e91f	2026-03-26	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794 ndc (product): 68016-292
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	c21147f5-da96-424c-9058-24eb751b64ea	2026-03-17	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794 ndc (product): 46122-448
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	b3e33137-bf40-4801-b01f-27a0d41edba4	2026-02-10	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794 ndc (product): 0363-9260
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	CVS Pharmacy	e4e3fd5f-1ed1-4a18-9c31-7224cae77ded	2024-10-03	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794 ndc (product): 69842-216

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9260	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9260	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
11822-3313	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3313	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3313	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
46122-448	Nicotine Polacrilex	Nicotine Polacrilex	AMERISOURCE BERGEN	ANDA	Current
46122-448	Nicotine Polacrilex	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-448	Nicotine Polacrilex	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-448	Nicotine Polacrilex	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-448	Nicotine Polacrilex	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
49035-512	Nicotine Polacrilex	Nicotine Polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-512	Nicotine Polacrilex	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-512	Nicotine Polacrilex	Nicotine Polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
63868-845	Nicotine	Nicotine Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-845	Nicotine	Nicotine Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-845	Nicotine	Nicotine Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
68016-292	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-292	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-292	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-292	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-292	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68196-013	Nicotine COATED ice mint	nicotine polacrilex	Sam's West, Inc.	ANDA	Current
68196-013	Nicotine COATED ice mint	nicotine polacrilex	Sam's West, Inc.	ANDA	Current
69842-216	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-216	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-216	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-216	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-216	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-216	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health, Inc.	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0348	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current