Home Applications 076789 Application 076789
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 A076789-001 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 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076789-001 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 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076789-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076789-001 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 A076789-001 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 · 15 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 62 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0170 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0170 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0170 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0170 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7170 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7170 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7170 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0904-5735 nicorelief Nicotine Polacrilex Major Pharmaceuticals ANDA Current 0904-5735 nicorelief Nicotine Polacrilex Major Pharmaceuticals ANDA Current 11673-170 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-170 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-170 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-170 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-170 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11822-0170 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0170 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0170 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 21130-522 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-522 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 30142-170 nicotine polacrilex Nicotine Polacrilex Kroger Company ANDA Current 30142-170 nicotine polacrilex Nicotine Polacrilex Kroger Company ANDA Current 30142-170 nicotine polacrilex Nicotine Polacrilex Kroger Company ANDA Current 36800-170 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-170 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-170 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 37808-170 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-170 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-849 nicotine nicotine H E B ANDA Current 37808-849 nicotine nicotine H E B ANDA Current 41163-170 equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41250-170 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-170 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-170 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-170 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41520-891 careone nicotine Nicotine Polacrilex American Sales Company ANDA Current 41520-891 careone nicotine Nicotine Polacrilex American Sales Company ANDA Current 46122-174 good neighbor pharmacy nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-174 good neighbor pharmacy nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-287 Good Neighbor Pharmacy Nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 49035-170 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-170 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-170 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-170 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49348-572 Sunmark Nicotine Nicotine Polacrilex McKesson ANDA Current 49348-572 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 49348-572 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 49348-572 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 59779-170 nicotine polacrilex Nicotine Polacrilex CVS Pharmacy ANDA Current 63981-170 kirkland signature quit 4 Nicotine Polacrilex Costco Wholesale Company ANDA Current 63981-170 kirkland signature quit 4 Nicotine Polacrilex Costco Wholesale Company ANDA Current 68196-170 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-170 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-170 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-170 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-170 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68391-170 berkley and jensen nicotine Nicotine Polacrilex BJWC ANDA Current 68391-170 berkley and jensen nicotine Nicotine Polacrilex BJWC ANDA Current 70000-0120 leader nicotine Nicotine Polacrilex Cardinal Health ANDA Current 70925-170 Humana Pharmacy Nicotine Nicotine Polacrilex Humana Pharmacy, Inc. ANDA Current 72288-170 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-170 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-170 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43106 ORIG 2007-05-09