Application 076778

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 4MG 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
A076778-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2004-09-16

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	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076778-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`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 26 · 507 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICOTINE	NICOTINE POLACRILEX	Amazon.com Services LLC	ec341a77-5b62-4980-8d31-27c12ae92561	2026-07-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	cd17f3b4-dddd-4387-9fb1-1efa32ba1d2b	2026-07-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	4ddba70a-3f45-4c76-a12a-6da256e9afc5	2026-07-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	c6c9582c-004d-4925-b147-add5f28f3856	2026-07-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	CVS Pharmacy	ab1407e3-9092-438c-b684-8194e4ee71af	2026-07-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	ecdfe02c-813b-4c1e-9e02-d7c544a89644	2026-07-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	P & L Development, LLC	3623455a-3f00-41d3-b17e-86a016da7047	2026-07-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	fd93fdf4-fa48-4373-aac7-894866a0b18d	2026-07-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	30e00817-75ff-43db-901c-c180e6730901	2026-07-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	00b40bb3-3785-4a53-804e-633795e87f71	2026-07-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	31b1a48e-8651-41d7-b693-6509a344906a	2026-07-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	da4c5203-76d7-454f-85bd-1717d95506bd	2026-07-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	2eca67db-1b7c-43dd-91af-4060e9b8e9d3	2026-07-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
EQUATE NICOTINE	NICOTINE POLACRILEX	WALMART INC.	b6379f86-1528-465d-9527-bd2fead0068f	2026-07-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
kirkland signature quit 2	NICOTINE POLACRILEX	Costco Wholesale Company	ccee1b99-e58b-4377-9ae8-9f215e2c975d	2026-07-14	Warnings	Name fallback generic name: NICOTINE POLACRILEX
kirkland signature quit 4	NICOTINE POLACRILEX	Costco Wholesale Company	bfdf3918-3116-4351-b0a8-4c515e2e1f41	2026-07-14	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Kirkland Signature Quit 2	NICOTINE POLACRILEX	Costco Wholesale Company	17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c1	2026-07-14	Warnings	Name fallback generic name: NICOTINE POLACRILEX
kirkland signature quit 4	NICOTINE POLACRILEX	Costco Wholesale Company	b9dd4e89-0023-4552-bdd6-1c046ce3bd87	2026-07-14	Warnings	Name fallback generic name: NICOTINE POLACRILEX
coated nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	97b06ada-b8b8-49fc-bc65-c3e835ef149b	2026-07-13	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	5c89061b-1452-4962-9f25-212f2ae8e41e	2026-07-13	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43104	ORIG	2007-05-09