Application 077656

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 4MG 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
A077656-001	THRIVE	NICOTINE POLACRILEX	EQ 4MG 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	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077656-001	THRIVE	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077656-001	THRIVE	EQ 4MG 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 18 of 26 · 517 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5d3b45d6-97c2-4400-ad09-95a4b21f5324	2025-12-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5c394758-1179-455a-a562-c8e954fb2258	2025-12-23	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	826f0ce5-9862-4f6f-8943-a3f06b07e69f	2025-12-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Habitrol Nicotine Polacrilex Gum 2 mg Coated Fruit	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	dc811e89-e104-4fdf-aabf-f73d41d85f4c	2025-12-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Kroger Company	69a61101-df32-444e-a49a-eccfeebfb20e	2025-12-11	Warnings	Name fallback generic name: NICOTINE POLACRILEX
mini nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	a5528828-cd03-46fc-a13c-3ccae1c0dc5c	2025-12-10	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	41ae65b3-2e4e-4306-959d-be44c7d205fe	2025-12-10	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	f3035ca0-8739-4d77-af97-f6021d6478c2	2025-12-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	6b500780-f45c-477c-8371-3b60e3305000	2025-12-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	Meijer, Inc.	084f9d77-b4ab-4328-8ff4-cdc7523daebe	2025-12-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	05990040-5bd7-4622-8fe3-2d7573904dfa	2025-12-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	a3f19365-d0d1-43ad-be15-48dc4320e361	2025-12-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	2025-12-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
QUITINE NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	5d23992f-a010-4604-b64c-94ab6b134e6d	2025-12-04	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	90232b4e-cbf4-4d03-973a-41f4ebb4e5de	2025-12-04	Warnings	Name fallback generic name: NICOTINE POLACRILEX
quitine mini nicotine	NICOTINE POLACRILEX	QUITINE LLC	0781ddbd-45c4-4191-898a-50c71644965c	2025-12-04	Warnings	Name fallback generic name: NICOTINE POLACRILEX
QUITINE MINI NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	d856379c-6334-4069-8382-ded2f86cf8a4	2025-12-04	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate nicotine	NICOTINE POLACRILEX	WALMART INC.	a4540259-78c1-4da2-a465-8a4cfe29a290	2025-11-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate nicotine	NICOTINE POLACRILEX	WALMART INC.	86c2cac9-4b7b-4b80-9ca1-32634304449e	2025-11-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	477689fc-688a-4c76-8c02-35a7a15adc5e	2025-11-19	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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