Home Applications 207868 Application 207868
Type ANDA
Sponsor PLD ACQUISITIONS 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 A207868-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 A207868-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07
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 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207868-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207868-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-02-07 782e0a99824c…
Observed Orange Book exclusivity history# 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 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mini Nicotine NICOTINE POLACRILEX WALMART INC. (see also Equate) 286e2768-ad98-43be-a3be-a2db0370f50f 2026-07-09 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 79903-128 Nicotine Mini NICOTINE POLACRILEX WALMART INC. (see also Equate) b49546cd-6cc4-422c-9a72-3a1faf2abcd3 2026-07-09 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 79903-127 Mini Nicotine NICOTINE POLACRILEX P & L Development, LLC b105adbd-b306-4944-a1d8-f209b74606c9 2026-06-24 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 Nicotine Mini NICOTINE POLACRILEX P & L Development, LLC 9ddc3fde-f384-41d2-93d5-077b6e419029 2026-06-24 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 59726-262 Mini Nicotine NICOTINE POLACRILEX Walgreens dfdd100d-8808-40f4-a68e-1e0388be424d 2026-05-08 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 0363-2640 Nicotine Mini NICOTINE POLACRILEX Walgreens 60551e9a-c82f-45ce-8ef4-03c00c6c870a 2026-05-06 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 0363-0262 Nicotine Mini NICOTINE POLACRILEX HC Jones, Inc. d0d1a5ef-fd4c-4854-9453-68808cc0fab0 2026-04-07 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 Mini Nicotine NICOTINE POLACRILEX HC Jones, Inc. ff9e34ff-5086-4e1b-9220-27ac2ac1069c 2026-04-07 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 Nicotine Sugar Free NICOTINE POLACRILEX CVS Pharmacy 9a96ba38-e696-4465-9869-9b269dc18f8d 2026-01-27 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 69842-662 Nicotine Mini NICOTINE POLACRILEX Rising Pharma Holdings, Inc. 05990040-5bd7-4622-8fe3-2d7573904dfa 2025-12-06 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 Mini Nicotine NICOTINE POLACRILEX Rugby Laboratories, Inc. 237471f8-ce0f-423b-993f-b4380fd890ff 2025-09-02 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 0536-1241 Nicotine Mini NICOTINE POLACRILEX Rite Aid Corporation 876b80a3-3ea8-4821-9716-c18e24502822 2025-08-20 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 11822-3315 Nicotine Mini NICOTINE POLACRILEX Rugby Laboratories, Inc. be17cbe9-43bb-424e-9d91-fba4f02691bb 2025-07-18 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 0536-1239 Mini Nicotine NICOTINE POLACRILEX Chain Drug Consortium, LLC 380ce6c2-3e29-4bdf-a600-f6990925a307 2025-06-30 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 68016-087 Nicotine Mini NICOTINE POLACRILEX ATLANTIC BIOLOGICALS CORP. 31e0dadd-2678-4e3c-9e62-e3766c21ce5f 2025-06-27 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 17856-1239 Mini Nicotine NICOTINE POLACRILEX ATLANTIC BIOLOGICALS CORP. a0fc3eae-9c34-48af-bdd2-d95e91b68a9c 2025-06-27 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 17856-1241 Nicotine Mini NICOTINE POLACRILEX PLD Acquisitions LLC DBA Avma Pharma Solutions 71db232e-b169-47d0-b269-5e14fa75f3a2 2025-03-27 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 63548-0262 ndc (product): 63548-0264 Mini Nicotine NICOTINE POLACRILEX EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 9b1d9efc-f74b-42f5-be84-5142ee168767 2025-01-30 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 49035-436 Mini Nicotine NICOTINE POLACRILEX AmerisourceBergen (Good Neighbor Pharmacy) 46122 7f1cdc21-d213-4ede-86fd-e11b31dfab58 2025-01-30 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 46122-716 Mini Nicotine NICOTINE POLACRILEX Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 4856d5df-3b77-465e-b6a9-38d00854f967 2023-10-23 Warnings Exact identifier application applno (ANDA): 207868 application number: ANDA207868
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 56 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0262 Nicotine Mini nicotine polacrilex Walgreens ANDA Current 0363-0262 Nicotine Mini nicotine polacrilex Walgreens ANDA Current 0363-0262 Nicotine Mini nicotine polacrilex Walgreens ANDA Current 0363-2640 Mini Nicotine nicotine polacrilex Walgreens ANDA Current 0363-2640 Mini Nicotine nicotine polacrilex Walgreens ANDA Current 0363-2640 Mini Nicotine nicotine polacrilex Walgreens ANDA Current 0536-1239 Nicotine Mini nicotine polacrilex Rugby Laboratories, Inc. ANDA Current 0536-1239 Nicotine Mini nicotine polacrilex Rugby Laboratories, Inc. ANDA Current 0536-1239 Nicotine Mini nicotine polacrilex Rugby Laboratories, Inc. ANDA Current 0536-1241 Mini Nicotine Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-1241 Mini Nicotine Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 0536-1241 Mini Nicotine Nicotine Polacrilex Rugby Laboratories, Inc. ANDA Current 11822-3315 Nicotine Mini nicotine polacrilex Rite Aid Corporation ANDA Current 11822-3315 Nicotine Mini nicotine polacrilex Rite Aid Corporation ANDA Current 11822-3622 Mini Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3622 Mini Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3622 Mini Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 17856-1239 Nicotine Mini nicotine polacrilex ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-1241 Mini Nicotine Nicotine Polacrilex ATLANTIC BIOLOGICALS CORP. ANDA Current 46122-715 Nicotine Mini nicotine polacrilex AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-716 Mini Nicotine Nicotine Polacrilex AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-716 Mini Nicotine Nicotine Polacrilex AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-731 Nicotine Mini nicotine polacrilex AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 49035-436 Mini Nicotine Nicotine Polacrilex EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-493 Nicotine Mini nicotine polacrilex EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) ANDA Current 49035-493 Nicotine Mini nicotine polacrilex EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-493 Nicotine Mini nicotine polacrilex EQUATE (Wal-Mart Stores, Inc.) ANDA Current 59726-262 Nicotine Mini nicotine polacrilex P & L Development, LLC ANDA Current 59726-262 Nicotine Mini nicotine polacrilex P & L Development, LLC ANDA Current 59726-262 Nicotine Mini nicotine polacrilex P & L Development, LLC ANDA Current 63548-0262 Nicotine nicotine polacrilex PLD Acquisitions LLC DBA Av ANDA Current 63548-0262 Nicotine nicotine polacrilex PLD Acquisitions LLC DBA Av ANDA Current 63548-0264 Nicotine nicotine polacrilex PLD Acquisitions LLC DBA Av ANDA Current 63548-0264 Nicotine nicotine polacrilex PLD Acquisitions LLC DBA Av ANDA Current 68016-086 Mini Nicotine nicotine polacrilex Chain Drug Consortium, LLC ANDA Current 68016-086 Mini Nicotine nicotine polacrilex Chain Drug Consortium, LLC ANDA Current 68016-087 Mini Nicotine nicotine polacrilex Chain Drug Consortium, LLC ANDA Current 68016-087 Mini Nicotine nicotine polacrilex Chain Drug Consortium, LLC ANDA Current 69842-564 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-564 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-564 Nicotine Nicotine Polacrilex CVS Pharmacy ANDA Current 69842-662 Nicotine nicotine polacrilex CVS Pharmacy ANDA Current 69842-662 Nicotine nicotine polacrilex CVS Pharmacy ANDA Current 69842-662 Nicotine nicotine polacrilex CVS Pharmacy ANDA Current 70000-0559 Nicotine Mini nicotine polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0559 Nicotine Mini nicotine polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0559 Nicotine Mini nicotine polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0560 Nicotine Mini nicotine polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0560 Nicotine Mini nicotine polacrilex Cardinal Health (Leader) 70000 ANDA Current 70000-0560 Nicotine Mini nicotine polacrilex Cardinal Health (Leader) 70000 ANDA Current 79903-127 Nicotine Mini nicotine polacrilex WALMART INC. (see also Equate) ANDA Current 79903-127 Nicotine Mini nicotine polacrilex WALMART INC. (see also Equate) ANDA Current 79903-127 Nicotine Mini nicotine polacrilex WALMART INC. (see also Equate) ANDA Current 79903-128 Mini Nicotine Nicotine Polacrilex WALMART INC. (see also Equate) ANDA Current 79903-128 Mini Nicotine Nicotine Polacrilex WALMART INC. (see also Equate) ANDA Current 79903-128 Mini Nicotine Nicotine Polacrilex WALMART INC. (see also Equate) ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71474 ORIG 2022-06-28