Home Applications 210711 Application 210711
Type ANDA
Sponsor P AND L 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 42 .
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 A210711-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 A210711-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31
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 2 · 80 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 2026-08-18 06:07:40 2026-07 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-10-31 bb7c543d1eb4…
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 · 10 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0979 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-0979 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-5760 Nicotine nicotine polacrilex Walgreens ANDA Current 0363-5760 Nicotine nicotine polacrilex Walgreens ANDA Current 0363-5760 Nicotine nicotine polacrilex Walgreens ANDA Current 0363-5770 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-5770 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-5770 Nicotine Nicotine Polacrilex Walgreens ANDA Current 0363-9780 Nicotine nicotine polacrilex Walgreens ANDA Current 0363-9780 Nicotine nicotine polacrilex Walgreens ANDA Current 11822-0903 Mini Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-0903 Mini Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-0903 Maxi Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-9902 Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-9902 Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 11822-9902 Nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 69842-934 Mini Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-934 Mini Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current