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 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 c2088c7a36db…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…
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 5 · 81 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 2 of 2 · 119 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55301-873 exchange select nicotine Nicotine Polacrilex Army & Air Force Exchange Service ANDA Current 55301-873 exchange select nicotine Nicotine Polacrilex Army & Air Force Exchange Service ANDA Current 55316-344 Healthy Accents Nicotine Nicotine Polacrilex DZA Brands LLC ANDA Current 56062-344 stop smoking aid Nicotine Polacrilex Publix Super Markets Inc ANDA Current 56062-344 stop smoking aid Nicotine Polacrilex Publix Super Markets Inc ANDA Current 56062-873 stop smoking aid Nicotine Polacrilex Publix Super Markets Inc ANDA Current 56062-873 stop smoking aid Nicotine Polacrilex Publix Super Markets Inc ANDA Current 59779-344 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-344 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-344 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-873 nicotine Nicotine polacrilex CVS Pharmacy ANDA Current 62011-0048 health mart nicotine polacrilex Nicotine Polacrilex McKesson ANDA Current 62011-0048 health mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0048 health mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0171 health mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0171 health mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0171 health mart nicotine polacrilex Nicotine Polacrilex McKesson ANDA Current 63981-344 kirkland signature quit 2 Nicotine Polacrilex Costco Wholesale Company ANDA Current 63981-873 kirkland signature quit 4 Nicotine Polacrilex Costco Wholesale Company ANDA Current 68196-082 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-082 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-082 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-873 Members Mark Nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-873 Members Mark Nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68258-7991 Good Sense Nicotine Nicotine Polacrilex Dispensing Solutions, Inc. ANDA Current 68258-7992 good sense nicotine Nicotine Polacrilex Dispensing Solutions, Inc. ANDA Current 68391-344 berkley and jensen nicotine Nicotine Polacrilex BJWC ANDA Current 68391-873 berkley and jensen nicotine polacrilex Nicotine Polacrilex BJWC ANDA Current 70000-0349 Leader Nicotine Nicotine Polacrilex Cardinal Health ANDA Current 70000-0349 Leader Nicotine Nicotine Polacrilex Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0350 leader nicotine Nicotine Polacrilex Cardinal Health ANDA Current 70000-0350 leader nicotine Nicotine Polacrilex Cardinal Health 110, LLC. dba Leader ANDA Current 72288-344 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-492 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-873 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-873 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-873 basic care nicotine Nicotine Polacrilex Amazon.com Services Inc. ANDA Current 72288-873 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 79903-101 euqate nicotine Nicotine Polacrilex WALMART INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31185 ORIG 2006-02-02