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 9 of 26 · 517 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLIP	NICOTINE POLACRILEX	Blip Products, Inc.	e48ba1fe-a9ad-4ff3-8f73-e08ae4072454	2026-05-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	8b6d7617-ce92-4bad-9f38-81a7f2e9cfa3	2026-05-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	ec88f367-ea8d-4bb9-80a6-71ba68412d38	2026-05-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c	2026-05-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
BLIP	NICOTINE POLACRILEX	Blip Products, Inc.	40e2b0e1-e049-4ec5-a4a8-138ad80b8420	2026-05-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	9e411b49-c8c4-43f8-a402-5ca2d96db131	2026-05-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	dd334b2c-bbae-48e7-8f3d-2706d325f600	2026-05-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	88e49664-1f09-431c-a96a-92605b79c812	2026-05-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	302f4785-77e6-433f-83d9-d0d2618d5ef2	2026-05-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	2026-05-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	486400cd-f2ef-4e14-8cf7-37954e1ed4d4	2026-05-20	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex original	NICOTINE POLACRILEX	Walgreens	f759d9b2-35e0-4b88-9219-4c0e483af5c4	2026-05-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex MINT	NICOTINE POLACRILEX	Walgreens	53c5ae28-5638-4217-9080-2bceba9a8885	2026-05-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	6020abb5-2a4f-4602-8014-e2b4e462c05f	2026-05-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex coated cinnamon	NICOTINE POLACRILEX	CVS Pharmacy	d9da6bd9-f655-446d-98b8-5b22db80dad2	2026-05-12	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	0ac7f87a-63f4-4d74-ba5b-d1444803b100	2026-05-11	Warnings	Name fallback generic name: NICOTINE POLACRILEX
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	71d1dcd2-e046-49ad-a28a-90e550a71104	2026-05-11	Warnings	Name fallback generic name: NICOTINE POLACRILEX
GOOD SENSE NICOTINE	NICOTINE POLACRILEX	L. Perrigo Company	632283a5-c617-4759-8933-7dc015e551c7	2026-05-11	Warnings	Name fallback generic name: NICOTINE POLACRILEX
GOOD SENSE NICOTINE	NICOTINE POLACRILEX	L. Perrigo Company	28843e89-9782-42bc-8afb-1059ef44d8f1	2026-05-11	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex original	NICOTINE POLACRILEX	CVS Pharmacy	62231539-ae9f-4665-ba59-bef047e93d8a	2026-05-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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