Home Applications 206393 Application 206393
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 4MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A206393-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG 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 · 43 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 2026-09-14 22:38:34 2026-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 f41ea6bd6efb…
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 2 of 3 · 47 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 75 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0053 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0053 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0713 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0713 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0713 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0363-2309 nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-2309 nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-2309 nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-7971 nicotine nicotine polacrilex Walgreen Company ANDA Current 0363-7971 nicotine nicotine polacrilex Walgreen Company ANDA Current 11673-309 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-309 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-309 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-309 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-971 up and up nicotine nicotine Target Corporation ANDA Current 11673-971 up and up nicotine nicotine Target Corporation ANDA Current 11673-971 up and up nicotine nicotine Target Corporation ANDA Current 11822-0309 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0309 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0309 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0971 nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-0971 nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-0971 nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 21130-173 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-173 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-820 signature care nicotine nicotine Safeway ANDA Current 21130-820 signature care nicotine nicotine Safeway ANDA Current 30142-309 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-309 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-309 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-848 nicotine nicotine polacrilex Kroger Company ANDA Current 30142-848 nicotine nicotine polacrilex Kroger Company ANDA Current 36800-650 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-650 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-967 topcare nicotine nicotine polacrilex Topco Associates LLC ANDA Current 36800-967 topcare nicotine nicotine polacrilex Topco Associates LLC ANDA Current 36800-967 topcare nicotine nicotine polacrilex Topco Associates LLC ANDA Current 37012-309 Nicotine Nicotine Polacrilex Shopko Stores Operating Co., LLC ANDA Current 37012-309 Nicotine Nicotine Polacrilex Shopko Stores Operating Co., LLC ANDA Current 37808-309 In Control Nicotine Nicotine Polacrilex H E B ANDA Current 37808-683 nicotine nicotine polacrilex H E B ANDA Current 37808-683 nicotine nicotine polacrilex H E B ANDA Current 37808-739 nicotine nicotine H E B ANDA Current 37808-739 nicotine nicotine H E B ANDA Current 41163-309 Equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41163-309 Equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41250-510 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-510 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-510 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-510 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-689 nicotine nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-689 nicotine nicotine polacrilex Meijer Distribution Inc ANDA Current 41520-843 careone nicotine Nicotine Polacrilex American Sales Company ANDA Current 41520-843 careone nicotine Nicotine Polacrilex American Sales Company ANDA Current 42884-309 zonnic nicotine Nicotine Polacrilex Niconovum USA Inc. ANDA Current 49035-309 equate nicotine nicotine polacrilex Wal-Mart Stores Inc ANDA Current 49035-309 equate nicotine nicotine polacrilex Wal-Mart Stores Inc ANDA Current 55910-606 DG Health nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 55910-606 DG Health nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 63981-309 kirkland signature quit 4 Nicotine Polacrilex Costco Wholesale Company ANDA Current 63981-309 kirkland signature quit 4 Nicotine Polacrilex Costco Wholesale Company ANDA Current 63981-309 kirkland signature quit 4 Nicotine Polacrilex Costco Wholesale Company ANDA Current 68196-309 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-309 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-309 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-309 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-971 Members Mark Nicotine nicotine polacrilex Sam's West Inc ANDA Current 68196-971 Members Mark Nicotine nicotine polacrilex Sam's West Inc ANDA Current 68196-971 Members Mark Nicotine nicotine polacrilex Sam's West Inc ANDA Current 68391-309 Berkley and Jensen Nicotine Nicotine Polacrilex BJWC ANDA Current 68391-309 Berkley and Jensen Nicotine Nicotine Polacrilex BJWC ANDA Current 68391-309 Berkley and Jensen Nicotine Nicotine Polacrilex BJWC ANDA Current 68391-309 Berkley and Jensen Nicotine Nicotine Polacrilex BJWC ANDA Current 70677-0170 sunmark nicotine nicotine polacrilex Strategic Sourcing Services LLC ANDA Current 72288-003 Basic Care Nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current