Home Applications 074507 Application 074507
Type ANDA
Sponsor P AND L Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING;BUCCAL EQ 2MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A074507-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 cb3db0bc1861…
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 · 11 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 45 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-1608 Nicotine Polacrilex Nicotine Polacrilex Walgreens ANDA Current 0363-1608 Nicotine Polacrilex Nicotine Polacrilex Walgreen Company ANDA Current 0363-1608 Nicotine Polacrilex Nicotine Polacrilex Walgreens ANDA Current 0363-1608 Nicotine Polacrilex Nicotine Polacrilex Walgreens ANDA Current 0363-1608 Nicotine Polacrilex Nicotine Polacrilex Walgreens ANDA Current 0363-1608 Nicotine Polacrilex Nicotine Polacrilex Walgreens ANDA Current 0363-9290 Nicotine nicotine polacrilex Walgreens ANDA Current 0363-9290 Nicotine nicotine polacrilex Walgreens ANDA Current 0536-3029 Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3029 Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3029 Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3029 Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3029 Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex Rugby Laboratories ANDA Current 11822-3328 Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-3328 Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 30142-859 Nicotine nicotine polacrilex The Kroger Co. ANDA Current 46122-719 Nicotine nicotine polacrilex AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 56062-608 Nicotine Polacrilex Nicotine Polacrilex Publix ANDA Current 56062-608 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-608 Nicotine Polacrilex Nicotine Polacrilex Publix ANDA Current 56062-608 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-608 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-608 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 63739-371 Nicotine nicotine polacrilex McKesson Corporation dba SKY Packaging ANDA Current 63739-371 Nicotine nicotine polacrilex McKesson Corporation dba SKY Packaging ANDA Current 63868-849 Nicotine nicotine polacrilex QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-849 Nicotine nicotine polacrilex QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 68016-286 Nicotine Polacrilex, Original Nicotine Polacrilex Chain Drug Consortium, LLC ANDA Current 68016-286 Nicotine Polacrilex, Original Nicotine Polacrilex Chain Drug Consortium, LLC ANDA Current 68016-286 Nicotine Polacrilex, Original Nicotine Polacrilex Chain Drug Consortium, LLC ANDA Current 68016-286 Nicotine Polacrilex, Original Nicotine Polacrilex Chain Drug Consortium, LLC ANDA Current 68016-286 Nicotine Polacrilex, Original Nicotine Polacrilex Chain Drug Consortium, LLC ANDA Current 68196-010 Nicotine nicotine polacrilex Sam's West, Inc. ANDA Current 68196-010 Nicotine nicotine polacrilex Sam's West, Inc. ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-608 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 70000-0345 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0345 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health, Inc. ANDA Current 70000-0345 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0345 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 18358 ORIG 2004-06-10 42849 ORIG 2003-04-30 8417 ORIG 1999-03-15