Home Applications 076779 Application 076779
Type ANDA
Sponsor L PERRIGO CO 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 A076779-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16
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 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 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 · 12 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 55 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0532 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0532 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7532 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7532 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7532 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0363-0919 Nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-0919 Nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-0919 Nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-0919 Nicotine Nicotine polacrilex Walgreen Company ANDA Current 11673-532 Up and Up nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-532 Up and Up nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-532 Up and Up nicotine Nicotine Polacrilex Target Corporation ANDA Current 11822-0699 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0699 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 30142-532 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 36800-532 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-532 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-532 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-532 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 37205-968 Leader Nicotine Nicotine Polacrilex Cardinal Health ANDA Current 37808-532 In Control Nicotine Nicotine Polacrilex H E B ANDA Current 37808-532 In Control Nicotine Nicotine Polacrilex H E B ANDA Current 37808-658 Nicotine nicotine H E B ANDA Current 37808-658 Nicotine nicotine H E B ANDA Current 37808-658 Nicotine nicotine H E B ANDA Current 41163-532 equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41250-532 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-532 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-532 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-532 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41520-110 CareOne Nicotine Nicotine Polacrilex American Sales Company ANDA Current 42884-532 zonnic nicotine polacrilex Nicotine Polacrilex Niconovum USA Inc. ANDA Current 46122-286 good neighbor pharmacy nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-286 good neighbor pharmacy nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-286 good neighbor pharmacy nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 49035-532 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-532 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-532 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-532 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49348-788 Sunmark Nicotine Nicotine Strategic Sourcing Services LLC ANDA Current 49348-788 Sunmark Nicotine Nicotine Strategic Sourcing Services LLC ANDA Current 49348-788 Sunmark Nicotine Nicotine Strategic Sourcing Services LLC ANDA Current 49348-788 Sunmark Nicotine Nicotine Strategic Sourcing Services LLC ANDA Current 49348-788 Sunmark Nicotine Nicotine McKesson ANDA Current 55319-719 family wellness nicotine Nicotine Polacrilex Family Dollar Services Inc ANDA Current 55319-719 family wellness nicotine Nicotine Polacrilex Family Dollar Services Inc ANDA Current 55319-719 family wellness nicotine Nicotine Polacrilex Family Dollar Services Inc ANDA Current 55319-719 family wellness nicotine Nicotine Polacrilex Family Dollar Services Inc ANDA Current 55910-532 Rexall Nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 55910-532 Rexall Nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 59779-532 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 68391-532 berkley and jensen nicotine Nicotine Polacrilex BJWC ANDA Current 70000-0123 Leader Nicotine Nicotine Polacrilex Cardinal Health ANDA Current 72288-532 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-532 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43105 ORIG 2007-05-09