Home Applications 090711 Application 090711
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 1 .
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 A090711-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 A090711-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10
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 · 82 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 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 782e0a99824c…
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 2 · 29 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 44 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-1125 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-1190 good sense nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7124 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7190 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7300 basic care nicotine nicotine polacrilex L. Perrigo Company ANDA Current 0363-0124 nicotine Nicotine polacrilex Walgreen Company ANDA Current 0363-4190 Nicotine Nicotine Polacrilex Walgreen Company ANDA Current 11673-124 up and up nicotine polacrilex Nicotine Polacrilex Target Corporation ANDA Current 11673-190 up and up nicotine polacrilex Nicotine Polacrilex Target Corporation ANDA Current 11822-0009 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0124 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0124 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 30142-124 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-124 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 30142-190 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 36800-375 topcare nicotine polacrilex Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-539 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 37808-124 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-124 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-190 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-190 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-383 nicotine nicotine H E B ANDA Current 37808-533 nicotine nicotine H E B ANDA Current 41250-190 nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-190 nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-700 nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-700 nicotine Nicotine polacrilex Meijer Distribution Inc ANDA Current 49035-124 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-124 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-190 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-190 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 59779-190 nicotine Nicotine polacrilex CVS Pharmacy ANDA Current 59779-397 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 59779-397 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 63981-124 Kirkland Signature Nicotine nicotine Costco Wholesale Company ANDA Current 63981-190 Kirkland Signature Nicotine nicotine Costco Wholesale Company ANDA Current 69256-124 Harris Teeter Nicotine Nicotine Polacrilex Harris Teeter, LLC ANDA Current 69256-190 Harris Teeter Nicotine Nicotine Polacrilex Harris Teeter, LLC ANDA Current 69842-433 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-433 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-917 Nicotine nicotine polacrilex CVS Pharmacy ANDA Current 72288-124 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-124 basic care nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current 72288-190 Basic Care Nicotine Nicotine Polacrilex Amazon.com Services LLC ANDA Current