Home Applications 077007 Application 077007
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 TROCHE/LOZENGE;ORAL EQ 2MG BASE No No 002 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE;ORAL 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077007-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 A077007-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31
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 3 · 86 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 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 74a2ff9319b5…
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 4 of 5 · 83 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 2 · 119 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0344 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0873 good sense nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7344 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7344 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7873 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7873 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0363-0411 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0411 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0873 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 0363-0873 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 11673-344 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-344 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-873 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11822-0344 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0873 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 21130-211 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-700 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-700 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-700 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-700 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-700 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 30142-344 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-344 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-873 Nicotine Nicotine polacrilex Kroger Company ANDA Current 30142-873 Nicotine Nicotine polacrilex Kroger Company ANDA Current 36800-344 Topcare Nicotine Polacrilex Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-873 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-873 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 37205-987 leader nicotine Nicotine Polacrilex Cardinal Health ANDA Current 37205-988 leader nicotine Nicotine Polacrilex Cardinal Health ANDA Current 37205-988 leader nicotine Nicotine Polacrilex Cardinal Health ANDA Current 37808-344 in control Nicotine Nicotine Polacrilex H E B ANDA Current 37808-344 in control Nicotine Nicotine Polacrilex H E B ANDA Current 37808-674 nicotine lozenge nicotine polacrilex H E B ANDA Current 37808-873 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-948 nicotine polacrilex nicotine H E B ANDA Current 41163-344 equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41163-344 equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41163-873 Equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41163-873 Equaline nicotine Nicotine Polacrilex Supervalu Inc ANDA Current 41250-344 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-344 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-344 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-873 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-873 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-873 nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41520-701 careone nicotine Nicotine Polacrilex American Sales Company ANDA Current 41520-873 care one nicotine Nicotine Polacrilex American Sales Company ANDA Current 45802-344 Nicotine Polacrilex Nicotine Polacrilex Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-344 Nicotine Polacrilex Nicotine Polacrilex Perrigo New York Inc ANDA Current 45802-873 Nicotine Polacrilex Nicotine Polacrilex Perrigo New York Inc ANDA Current 45802-873 Nicotine Polacrilex Nicotine Polacrilex Padagis Israel Pharmaceuticals Ltd ANDA Current 46122-176 Good Neighbor Pharmacy Nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-177 Good Neighbor Pharmacy Nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 49035-873 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-873 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-873 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-873 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-998 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-998 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-998 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-998 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-998 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49348-852 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 49348-852 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 49348-852 Sunmark Nicotine Nicotine Polacrilex McKesson ANDA Current 49348-853 Sunmark Nicotine Nicotine Polacrilex McKesson ANDA Current 49348-853 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 49348-853 Sunmark Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 50090-1152 Nicotine Polacrilex Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1152 Nicotine Polacrilex Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1152 Nicotine Polacrilex Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1153 Sunmark Nicotine Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1154 Nicotine Polacrilex Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1154 Nicotine Polacrilex Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1154 Nicotine Polacrilex Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1155 Sunmark Nicotine Nicotine Polacrilex A-S Medication Solutions ANDA Current 50090-1155 Sunmark Nicotine Nicotine Polacrilex A-S Medication Solutions ANDA Current 55301-617 exchange select nicotine Nicotine Polacrilex Army & Air Force Exchange Service ANDA Current 55301-617 exchange select nicotine Nicotine Polacrilex Army & Air Force Exchange Service ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31185 ORIG 2006-02-02