Application 076569

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
002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 4MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076569-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2004-07-29

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`e64feba35796…`

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	NICOTINE POLACRILEX	Rugby Laboratories	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	2026-07-10	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569 ndc (product): 0536-1362
Nicotine Polacrilex MINT	NICOTINE POLACRILEX	Walgreens	53c5ae28-5638-4217-9080-2bceba9a8885	2026-05-19	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569 ndc (product): 0363-1420
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	5efd7a3c-b36c-4355-a646-bfeb7ba30ce5	2026-03-17	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569 ndc (product): 46122-724
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	A-S Medication Solutions	7b70162e-0087-466f-9b8b-8289b6e90e39	2025-09-23	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569 ndc (product): 50090-3560
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	ATLANTIC BIOLOGICALS CORP.	62609a8d-bcbe-420c-aed8-edfdf022ff26	2025-06-27	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569 ndc (product): 17856-1362

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-1420	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-1420	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-1420	Nicotine Polacrilex	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-1420	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-1420	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0536-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	Rugby Laboratories	ANDA	Current
0536-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
17856-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1362	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
46122-724	Nicotine	nicotine polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
50090-3560	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	A-S Medication Solutions	ANDA	Current
50090-3560	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	A-S Medication Solutions	ANDA	Current
50090-3560	Rugby Nicotine Polacrilex Gum, Mint Flavor	Nicotine Polacrilex	A-S Medication Solutions	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31141	ORIG	2004-07-30