Application 077658
- Type
- ANDA
- Sponsor
- GLAXOSMITHKLINE CONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THRIVE | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 2MG BASE | No | No |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077658-001 | THRIVE | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2007-06-19 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nicotine | NICOTINE POLACRILEX | Walgreens | 97ce52b1-d98e-4216-99c2-7e341c8fec43 | 2026-08-25 | Warnings | NICOTINE POLACRILEX |
| NICOTINE MINI | NICOTINE POLACRILEX | Amazon.com Services LLC | b957f757-2b34-49b2-a68b-a7bc9e8dd8b2 | 2026-08-21 | Warnings | NICOTINE POLACRILEX |
| NICOTINE | NICOTINE POLACRILEX | Walgreen Company | 5dd116ea-d031-439c-b06c-2f77230bc446 | 2026-08-20 | Warnings | NICOTINE POLACRILEX |
| nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | e40a534e-8083-454d-9667-826bfbac397c | 2026-08-19 | Warnings | NICOTINE POLACRILEX |
| nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | bc1b6b41-d069-470e-90ca-a441ab97f96a | 2026-08-18 | Warnings | NICOTINE POLACRILEX |
| Mini Nicotine | NICOTINE POLACRILEX | WALMART INC. (see also Equate) | 286e2768-ad98-43be-a3be-a2db0370f50f | 2026-08-12 | Warnings | NICOTINE POLACRILEX |
| Nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | 4ab742f2-2599-4d9f-83c5-9338d66ad6cf | 2026-08-12 | Warnings | NICOTINE POLACRILEX |
| Nicotine Mini | NICOTINE POLACRILEX | WALMART INC. (see also Equate) | b49546cd-6cc4-422c-9a72-3a1faf2abcd3 | 2026-08-12 | Warnings | NICOTINE POLACRILEX |
| Nicotine | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | a33b6ed6-2c75-4bab-98e5-a7f8bea21926 | 2026-08-12 | Warnings | NICOTINE POLACRILEX |
| Nicotine | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 9ba85e0a-bcb7-4803-8d21-0eb93768cb3a | 2026-08-07 | Warnings | NICOTINE POLACRILEX |
| QUITINE NICOTINE | NICOTINE POLACRILEX | QUITINE LLC | 1f93571c-4bd2-4272-ab9f-240b7c8a024b | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| Nicotine | NICOTINE POLACRILEX | P & L Development, LLC | 30e00817-75ff-43db-901c-c180e6730901 | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| Quitine Nicotine | NICOTINE POLACRILEX | QUITINE LLC | 4cc32b8c-6316-4d4b-8fa9-ef640464ca69 | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| NICOTINE GUM | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 4e88dab4-8e13-f074-e063-6394a90a3908 | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| Oneoo Nicotine Gum (Mint) | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 54b1329b-b422-29a5-e063-6294a90a8780 | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| Nicotine Mini | NICOTINE POLACRILEX | P & L Development, LLC | 3623455a-3f00-41d3-b17e-86a016da7047 | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| Quitine Nicotine | NICOTINE POLACRILEX | QUITINE LLC | 10e3e1ac-2f78-4ce4-8f38-a283fac99660 | 2026-08-06 | Warnings | NICOTINE POLACRILEX |
| nicotine | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ecd78195-2df2-401d-b590-2c1cb764df5c | 2026-08-05 | Warnings | NICOTINE POLACRILEX |
| NICOTINE | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ecf97d6b-6ca7-48c1-8c37-029421689cc1 | 2026-08-05 | Warnings | NICOTINE POLACRILEX |
| nicotine | NICOTINE POLACRILEX | CVS Pharmacy | cb9189d6-0593-426d-8ff5-357a4c9180f6 | 2026-08-05 | Warnings | NICOTINE POLACRILEX |