Application 079044

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
A079044-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2009-07-08

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	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079044-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	ac252ff2-b4a8-4be2-9ec8-08f76c8ab908	2026-06-22	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044
Nicotine Polacrilex coated fruit	NICOTINE POLACRILEX	CVS Pharmacy	8c5e99d7-9d2d-488b-a804-496edafd30cf	2026-05-05	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044 ndc (product): 69842-024
Nicotine Polacrilex Coated Fruit	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	d6c7a2ab-109d-40df-bce0-30c3531eb982	2026-04-10	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044 ndc (product): 70000-0346
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	NICOTINE POLACRILEX	Rugby Laboratories	b973d045-7791-49c1-9216-4e0d51173735	2026-02-27	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044 ndc (product): 0536-3386
Nicotine Polacrilex Coated Fruit	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	c161e2d6-7691-4fd0-9f91-acfc33685420	2026-02-23	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044 ndc (product): 56062-503
Nicotine	NICOTINE POLACRILEX	Walgreens	cce1153e-ad7b-4c8a-a4eb-5b08b4652688	2026-02-04	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044 ndc (product): 0363-9250
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	6d895db2-7423-42bc-ae78-e0b47189e2d2	2026-01-16	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044 ndc (product): 55301-503
Habitrol Nicotine Polacrilex Gum 2 mg Coated Fruit	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	dc811e89-e104-4fdf-aabf-f73d41d85f4c	2025-12-22	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	a18dde9f-700f-4572-a6aa-577dbacdf314	2025-07-29	Warnings	Exact identifier application applno (ANDA): 079044 application number: ANDA079044

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9250	Nicotine	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9250	Nicotine	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9250	Nicotine	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9250	Nicotine	Nicotine Polacrilex	Walgreens	ANDA	Current
0536-3386	Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	Nicotine Polacrilex	Rugby Laboratories	ANDA	Current
0536-3386	Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3386	Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3386	Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3386	Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
11822-3322	Nicotine Polacrilex Gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3322	Nicotine Polacrilex Gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3322	Nicotine Polacrilex Gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3322	Nicotine Polacrilex Gum	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
55301-503	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
55301-503	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
55301-503	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
55301-503	Nicotine Polacrilex	Nicotine Polacrilex	Army and Air Force Exchange Service	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-503	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
63868-844	Nicotine	Nicotine Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-844	Nicotine	Nicotine Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-844	Nicotine	Nicotine Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
66715-9805	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9805	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9805	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9805	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
68196-015	Nicotine Coated Fruit Flavor	nicotine polacrilex	Sam's West, Inc.	ANDA	Current
68196-015	Nicotine Coated Fruit Flavor	nicotine polacrilex	Sam's West, Inc.	ANDA	Current
69842-024	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-024	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-024	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-024	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-024	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-024	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health, Inc.	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0346	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current