Home Applications 091349 Application 091349
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 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 A091349-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20
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 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 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 8 of 26 · 518 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 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0365 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0365 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0365 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0365 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0365 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0365 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 11673-365 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-365 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-365 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-365 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11822-0365 nicotine gum Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0365 nicotine gum Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0365 nicotine gum Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0365 nicotine gum Nicotine Polacrilex Rite Aid Corporation ANDA Current 41250-365 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-365 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-365 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-365 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-365 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 42884-365 Zonnic Nicotine Polacrilex Nicotine Polacrilex Niconovum USA Inc. ANDA Current 49035-365 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-365 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-365 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 59779-637 nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 68196-365 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-365 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current