Application 079216

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
A079216-001	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	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079216-001	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	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079216-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079216-001	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	A079216-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex coated cinnamon	NICOTINE POLACRILEX	CVS Pharmacy	d9da6bd9-f655-446d-98b8-5b22db80dad2	2026-05-12	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216 ndc (product): 69842-026
Nicotine	NICOTINE POLACRILEX	H E B	526bc299-657a-4899-aa72-04e151a38cba	2026-04-02	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216 ndc (product): 37808-820
Nicotine Polacrilex	NICOTINE POLACRILEX	Rugby Laboratories	d67149d5-4766-4b84-8205-f1a6b692f4c9	2026-02-26	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216 ndc (product): 0536-3404
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	b1174e20-e1ad-4c58-8b32-683b7e98fca9	2026-02-10	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216 ndc (product): 0363-9240
Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	6874a9f1-d180-4073-8226-df6e21bcf0b7	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216
Nicotine Polacrilex	NICOTINE POLACRILEX	Rite Aid Corporation	63a433aa-8c73-47a0-be64-8708f8478fff	2025-08-07	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216 ndc (product): 11822-2331
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	76034dd1-361c-442c-92aa-8fa7cf47a507	2025-07-18	Warnings	Exact identifier application applno (ANDA): 079216 application number: ANDA079216

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9240	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9240	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9240	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9240	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0536-3404	Nicotine Polacrilex	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3404	Nicotine Polacrilex	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3404	Nicotine Polacrilex	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3404	Nicotine Polacrilex	Nicotine Polacrilex	Rugby Laboratories	ANDA	Current
0536-3404	Nicotine Polacrilex	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
11822-2331	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-2331	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-2331	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-2331	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
37808-820	Nicotine	Nicotine Polacrilex	H E B	ANDA	Current
49035-387	Nicotine	Nicotine Polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-387	Nicotine	Nicotine Polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
63739-370	Nicotine	Nicotine Polacrilex	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-370	Nicotine	Nicotine Polacrilex	McKesson Corporation dba SKY Packaging	ANDA	Current
66715-9804	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9804	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9804	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9804	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9804	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
69842-026	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-026	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-026	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-026	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current