Home Applications 206394 Application 206394
Type ANDA
Sponsor PERRIGO R AND D 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 A206394-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15
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 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 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 3 · 41 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 74 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0704 basic care nicotine Nicotine polacrilex L. Perrigo Company ANDA Current 0113-0704 basic care nicotine Nicotine polacrilex L. Perrigo Company ANDA Current 0113-0704 basic care nicotine Nicotine polacrilex L. Perrigo Company ANDA Current 0363-1012 nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-1012 nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-1012 nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-7269 NICOTINE nicotine polacrilex Walgreen Company ANDA Current 0363-7269 NICOTINE nicotine polacrilex Walgreen Company ANDA Current 0363-7269 NICOTINE nicotine polacrilex Walgreen Company ANDA Current 11673-269 up and up nicotine nicotine Target Corporation ANDA Current 11673-269 up and up nicotine nicotine Target Corporation ANDA Current 11673-269 up and up nicotine nicotine Target Corporation ANDA Current 11673-411 up and up nicotine Nicotine polacrilex Target Corporation ANDA Current 11673-411 up and up nicotine Nicotine polacrilex Target Corporation ANDA Current 11673-411 up and up nicotine Nicotine polacrilex Target Corporation ANDA Current 11673-411 up and up nicotine Nicotine polacrilex Target Corporation ANDA Current 11822-0269 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0269 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0904 nictoine gum Nicotine polacrilex Rite Aid Corporation ANDA Current 11822-0904 nictoine gum Nicotine polacrilex Rite Aid Corporation ANDA Current 11822-0904 nictoine gum Nicotine polacrilex Rite Aid Corporation ANDA Current 21130-186 signature care nicotine Nicotine polacrilex Safeway ANDA Current 21130-186 signature care nicotine Nicotine polacrilex Safeway ANDA Current 21130-269 signature care nicotine nicotine Safeway ANDA Current 21130-269 signature care nicotine nicotine Safeway ANDA Current 30142-208 Nicotine Nicotine polacrilex Kroger Company ANDA Current 30142-208 Nicotine Nicotine polacrilex Kroger Company ANDA Current 30142-208 Nicotine Nicotine polacrilex Kroger Company ANDA Current 30142-749 nicotine nicotine polacrilex Kroger Company ANDA Current 30142-749 nicotine nicotine polacrilex Kroger Company ANDA Current 30142-749 nicotine nicotine polacrilex Kroger Company ANDA Current 36800-269 topcare nicotine nicotine polacrilex Topco Associates LLC ANDA Current 36800-269 topcare nicotine nicotine polacrilex Topco Associates LLC ANDA Current 36800-269 topcare nicotine nicotine polacrilex Topco Associates LLC ANDA Current 36800-863 Topcare Nicotine Gum Nicotine polacrilex Topco Associates LLC ANDA Current 36800-863 Topcare Nicotine Gum Nicotine polacrilex Topco Associates LLC ANDA Current 37012-012 Nicotine Nicotine polacrilex Shopko Stores Operating Co., LLC ANDA Current 37012-012 Nicotine Nicotine polacrilex Shopko Stores Operating Co., LLC ANDA Current 37808-349 Nicotine Nicotine polacrilex H E B ANDA Current 37808-711 Nicotine nicotine H E B ANDA Current 37808-711 Nicotine nicotine H E B ANDA Current 37808-909 nicotine nicotine polacrilex H E B ANDA Current 37808-909 nicotine nicotine polacrilex H E B ANDA Current 41163-012 equaline nicotine Nicotine polacrilex Supervalu Inc ANDA Current 41163-012 equaline nicotine Nicotine polacrilex Supervalu Inc ANDA Current 41250-209 Nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-209 Nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-209 Nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-529 nicotine nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-529 nicotine nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-529 nicotine nicotine polacrilex Meijer Distribution Inc ANDA Current 41520-711 careone nicotine Nicotine polacrilex American Sales Company ANDA Current 41520-711 careone nicotine Nicotine polacrilex American Sales Company ANDA Current 42884-012 Zonnic nicotine Nicotine polacrilex Niconovum USA Inc. ANDA Current 49035-415 equate nicotine nicotine polacrilex Wal-Mart Stores Inc ANDA Current 49035-415 equate nicotine nicotine polacrilex Wal-Mart Stores Inc ANDA Current 63981-012 Kirkland Signature Quit 2 Nicotine polacrilex Costco Wholesale Company ANDA Current 63981-012 Kirkland Signature Quit 2 Nicotine polacrilex Costco Wholesale Company ANDA Current 63981-012 Kirkland Signature Quit 2 Nicotine polacrilex Costco Wholesale Company ANDA Current 63981-012 Kirkland Signature Quit 2 Nicotine polacrilex Costco Wholesale Company ANDA Current 68196-012 Members Mark Nicotine Nicotine polacrilex Sam's West Inc ANDA Current 68196-012 Members Mark Nicotine Nicotine polacrilex Sam's West Inc ANDA Current 68196-012 Members Mark Nicotine Nicotine polacrilex Sam's West Inc ANDA Current 68196-012 Members Mark Nicotine Nicotine polacrilex Sam's West Inc ANDA Current 68196-269 members mark nicotine nicotine polacrilex Sam's West Inc ANDA Current 68196-269 members mark nicotine nicotine polacrilex Sam's West Inc ANDA Current 68196-269 members mark nicotine nicotine polacrilex Sam's West Inc ANDA Current 68196-269 members mark nicotine nicotine polacrilex Sam's West Inc ANDA Current 68391-012 Berkley and Jensen NICOTINE Nicotine polacrilex BJWC ANDA Current 68391-012 Berkley and Jensen NICOTINE Nicotine polacrilex BJWC ANDA Current 68391-012 Berkley and Jensen NICOTINE Nicotine polacrilex BJWC ANDA Current 68391-012 Berkley and Jensen NICOTINE Nicotine polacrilex BJWC ANDA Current 70677-0169 sunmark nicotine nicotine polacrilex Strategic Sourcing Services LLC ANDA Current 72288-292 Basic Care Nicotine Nicotine polacrilex Amazon.com Services LLC ANDA Current