Home Applications 079038 Application 079038
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 4MG 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 A079038-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08
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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 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 · 10 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 50 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-9310 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-9310 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-9310 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-9310 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0536-3387 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex Rugby Laboratories ANDA Current 0536-3387 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3387 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3387 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-3387 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 11822-3337 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3337 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3337 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3337 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3337 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 55301-504 Nicotine Polacrilex Nicotine Polacrilex AAFES/Your Military Exchanges ANDA Current 55301-504 Nicotine Polacrilex Nicotine Polacrilex AAFES/Your Military Exchanges ANDA Current 55301-504 Nicotine Polacrilex Nicotine Polacrilex AAFES/Your Military Exchanges ANDA Current 55301-504 Nicotine Polacrilex Nicotine Polacrilex Army and Air Force Exchange Service ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 56062-504 Nicotine Polacrilex Nicotine Polacrilex Publix Supermarkets, Inc. ANDA Current 63739-368 Nicotine Nicotine Polacrilex McKesson Corporation dba SKY Packaging ANDA Current 63739-368 Nicotine Nicotine Polacrilex McKesson Corporation dba SKY Packaging ANDA Current 63868-842 Nicotine Nicotine Polacrilex QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-842 Nicotine Nicotine Polacrilex QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-842 Nicotine Nicotine Polacrilex QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 66715-9802 Nicotac Nicotine Polacrilex Nicotine Lil' Drug Store Products, Inc. ANDA Current 66715-9802 Nicotac Nicotine Polacrilex Nicotine Lil' Drug Store Products, Inc. ANDA Current 66715-9802 Nicotac Nicotine Polacrilex Nicotine Lil' Drug Store Products, Inc. ANDA Current 66715-9802 Nicotac Nicotine Polacrilex Nicotine Lil' Drug Store Products, Inc. ANDA Current 68196-016 Nicotine Coated Fruit Flavor nicotine polacrilex Sam's West, Inc. ANDA Current 68196-016 Nicotine Coated Fruit Flavor nicotine polacrilex Sam's West, Inc. ANDA Current 68196-016 Nicotine Coated Fruit Flavor nicotine polacrilex Sam's West, Inc. ANDA Current 69842-025 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-025 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-025 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-025 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-025 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-025 Nicotine Polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health, Inc. ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0342 Nicotine Polacrilex Nicotine Polacrilex Cardinal Health (Leader) 70000 ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22633 ORIG 2013-02-25