Application 077658

Type: ANDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THRIVE	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 2MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077658-001	THRIVE	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2007-06-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077658-001	THRIVE	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`f41ea6bd6efb…`

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 6 of 26 · 517 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nicotine	NICOTINE POLACRILEX	Kroger Company	3621f5df-f036-4d9f-9972-40e47912d713	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	fa4d83cd-5998-440c-9d20-1d880996994d	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	1055f032-3a6e-40d3-8343-d144953c143d	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	860f8306-4cd4-4444-8c6e-182ddeb10ad6	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	bbeb84ae-c98f-422e-9770-e44961af593f	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	3a408d89-974f-4a20-aee9-fb1fe0a7ef3e	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	9a1c3e96-9a12-448b-a732-e4eb277327f7	2026-06-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	b105adbd-b306-4944-a1d8-f209b74606c9	2026-06-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Foster and Thrive Nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	f2d0bf82-3cc7-4b06-9f2d-0c927416f6cf	2026-06-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	P & L Development, LLC	9ddc3fde-f384-41d2-93d5-077b6e419029	2026-06-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e1	2026-06-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	aff57914-5af5-46b6-8f80-9db518750843	2026-06-24	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	ac252ff2-b4a8-4be2-9ec8-08f76c8ab908	2026-06-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	Publix Super Markets Inc	d043920e-d795-4eff-aadd-4c81b01503ea	2026-06-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	fbb3f6af-529f-40d8-a193-1aed4f2aa769	2026-06-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
signature care nicotine	NICOTINE POLACRILEX	Safeway	bcf4407a-b0ff-40bb-9bb9-6c36bdd525fc	2026-06-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
TopCare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	beb2eddc-0fec-4f64-bceb-4e9bcee3616c	2026-06-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	59ba5cba-be1e-4708-a9ab-01f43543bb5b	2026-06-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Care One Nicotine	NICOTINE POLACRILEX	American Sales Company	78cf8b14-cdad-464c-afb5-9fc49ebc3921	2026-06-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	fa916f6b-0582-4e2a-bbed-6c47778c5d03	2026-06-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.