Home Applications 020066 Application 020066
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 NICORETTE NICOTINE POLACRILEX GUM, CHEWING;BUCCAL EQ 4MG BASE Yes Yes 003 NICORETTE (MINT) NICOTINE POLACRILEX GUM, CHEWING;BUCCAL EQ 4MG BASE Yes No 004 NICORETTE NICOTINE POLACRILEX GUM, CHEWING;BUCCAL EQ 4MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020066-002 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 N020066-003 NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 N020066-004 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N020066-002 8323683 2028-04-30 Drug product 2013-01-03
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 4 · 126 observed states.
Captured, Edition, Application-product table 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 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 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.
Matched openFDA labels page 1 of 1 · 7 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0135-0158 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0158 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0226 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0226 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0230 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0230 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0242 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0242 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0355 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0355 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0467 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0467 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0475 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0475 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0533 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0533 Nicorette nicotine polacrilex GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 29485-5270 Nicorette Fruit Chill nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5270 Nicorette Fruit Chill nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5270 Nicorette Fruit Chill nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5270 Nicorette Fruit Chill nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5271 Nicorette White Mint nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5271 Nicorette White Mint nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5271 Nicorette White Mint nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current 29485-5271 Nicorette White Mint nicotine polacrilex Nicotine Mechanical Servants LLC NDA Current