Home Applications 203690 Application 203690
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 A203690-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 A203690-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09
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 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 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 1 of 5 · 84 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 · 146 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49035-900 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-900 Equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-957 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-957 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-957 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 50594-734 sound body nicotine Nicotine Polacrilex Big Lots Stores, Inc. ANDA Current 55301-734 exchange select nicotine Nicotine Polacrilex Army & Air Force Exchange Service ANDA Current 55301-957 exchange select nicotine Nicotine Polacrilex Army & Air Force Exchange Service ANDA Current 55910-957 Rexall Nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 55910-957 Rexall Nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 55910-957 Rexall Nicotine Nicotine Polacrilex Dolgencorp, LLC ANDA Current 59779-734 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-734 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-957 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-957 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 62011-0199 Health Mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0199 Health Mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0199 Health Mart nicotine polacrilex Nicotine Polacrilex McKesson ANDA Current 62011-0200 Health Mart Nicotine Nicotine Polacrilex Mckesson ANDA Current 62011-0200 Health Mart Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0200 Health Mart Nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0429 health mart nicotine polacrilex nicotine polacrilex Strategic Sourcing Services LLC ANDA Current 62011-0430 health mart nicotine polacrilex Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 68196-084 members mark nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-734 members mark Nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-734 members mark Nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-734 members mark Nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-811 members mark nicotine nicotine polacrilex Sam's West Inc ANDA Current 68196-957 members mark mini nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-957 members mark mini nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-957 members mark mini nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68196-957 members mark mini nicotine Nicotine Polacrilex Sam's West Inc ANDA Current 68391-023 Berkley and Jensen Nicotine Nicotine Polacrilex BJWC ANDA Current 68391-734 berkley and jensen nicotine Nicotine Polacrilex BJWC ANDA Current 68391-800 bjwc nicotine nicotine polacrilex BJWC ANDA Current 68391-957 berkley and jensen nicotine Nicotine Polacrilex BJWC ANDA Current 69256-734 Harris Teeter Nicotine Nicotine Polacrilex Harris Teeter, LLC ANDA Current 69256-734 Harris Teeter Nicotine Nicotine Polacrilex Harris Teeter, LLC ANDA Current 69256-957 Harris Teeter Nicotine Nicotine Polacrilex Harris Teeter, LLC ANDA Current 69256-957 Harris Teeter Nicotine Nicotine Polacrilex Harris Teeter, LLC ANDA Current 69842-605 nicotine nicotine CVS Pharmacy ANDA Current 69842-769 Nicotine nicotine polacrilex CVS Pharmacy ANDA Current 69842-828 nicotine nicotine CVS Pharmacy ANDA Current 69842-919 Nicotine nicotine polacrilex CVS Pharmacy ANDA Current 70000-0117 Leader Nicotine Nicotine Polacrilex Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0117 Leader Nicotine Nicotine Polacrilex Cardinal Health ANDA Current 70000-0121 Leader Nicotine Nicotine Polacrilex Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0121 Leader Nicotine Nicotine Polacrilex Cardinal Health ANDA Current 70677-0089 sunmark nicotine nicotine polacrilex Strategic Sourcing Services LLC ANDA Current 70677-0090 sunmark nicotine Nicotine Polacrilex Strategic Sourcing Services LLC ANDA Current 72224-000 lucy nicotine nicotine polacrilex Lucy Goods, INC. ANDA Current 72224-017 Lucy nicotine Nicotine Polacrilex Lucy Goods, Inc. ANDA Current 72224-017 Lucy nicotine Nicotine Polacrilex Lucy Goods, INC. ANDA Current 72224-870 lucy nicotine Nicotine Polacrilex Lucy Goods, INC. ANDA Current 72288-077 Basic Care Nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-223 basic care nicotine nicotine polacrilex Amazon.com Services LLC ANDA Current 72288-223 basic care nicotine nicotine polacrilex Amazon.com Services LLC ANDA Current 72288-642 basic care nicotine nicotine polacrilex Amazon.com Services LLC ANDA Current 72288-642 basic care nicotine nicotine polacrilex Amazon.com Services LLC ANDA Current 72288-734 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-734 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-808 basic care nicotine nicotine polacrilex Amazon.com Services LLC ANDA Current 72288-957 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-957 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 79903-104 equate nicotine nicotine polacrilex WALMART INC. ANDA Current 79903-160 equate nicotine nicotine polacrilex WALMART INC. ANDA Current