Application 209206
- Type
- ANDA
- Sponsor
- P AND L
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209206-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | ||
| A209206-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 |
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.
| 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 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209206-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209206-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2018-06-26 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nicotine | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | a33b6ed6-2c75-4bab-98e5-a7f8bea21926 | 2026-08-12 | Warnings | 209206 ANDA209206 46122-734 |
| Nicotine | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 39640129-2d7a-4ec5-81a1-e14b11d3d3ee | 2026-03-12 | Warnings | 209206 ANDA209206 46122-732 |
| Nicotine | NICOTINE POLACRILEX | Walgreens | 25dc2032-4e6a-440a-8327-7b6c877a2430 | 2026-01-20 | Warnings | 209206 ANDA209206 0363-9570 |
| Nicotine | NICOTINE POLACRILEX | Walgreens | 49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f4 | 2026-01-20 | Warnings | 209206 ANDA209206 0363-9580 |
| Nicotine Sugar Free | NICOTINE POLACRILEX | CVS Pharmacy | a275ff04-4078-4783-932b-dde9aee04682 | 2025-08-26 | Warnings | 209206 ANDA209206 69842-858 |
| Nicotine Sugar Free | NICOTINE POLACRILEX | CVS Pharmacy | 63fce25d-457f-4048-86a4-1805f603936c | 2025-08-26 | Warnings | 209206 ANDA209206 69842-957 |
| Maxi Nicotine | NICOTINE POLACRILEX | Rite Aid Corporation | 1472b0a3-5ff1-44e7-8748-a3b1a5e55196 | 2025-08-25 | Warnings | 209206 ANDA209206 11822-3317 |
| Nicotine | NICOTINE POLACRILEX | Rugby Laboratories, Inc. | 150faf42-491f-403b-869b-48edd431d1cc | 2025-07-18 | Warnings | 209206 ANDA209206 0536-1337 |
| Maxi Nicotine | NICOTINE POLACRILEX | Rugby Laboratories, Inc. | 7c2e0872-75f6-4c4f-afff-3579375708de | 2025-07-18 | Warnings | 209206 ANDA209206 0536-1338 |
| Nicotine | NICOTINE POLACRILEX | Cardinal Health (Leader) 70000 | 80195d3b-9341-4354-8a65-b5b080b524d0 | 2025-02-26 | Warnings | 209206 ANDA209206 70000-0562 |
| Maxi Nicotine | NICOTINE POLACRILEX | Cardinal Health (Leader) 70000 | 362b4a04-4a5f-4af6-9cd7-82aa172b7afb | 2025-02-26 | Warnings | 209206 ANDA209206 70000-0561 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-9570 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9570 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9570 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9570 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9570 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9580 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9580 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9580 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0363-9580 | Nicotine | nicotine polacrilex | Walgreens | ANDA | Current |
| 0536-1337 | Nicotine | nicotine polacrilex | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1337 | Nicotine | nicotine polacrilex | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1338 | Maxi Nicotine | nicotine polacrilex | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1338 | Maxi Nicotine | nicotine polacrilex | Rugby Laboratories, Inc. | ANDA | Current |
| 11822-3316 | Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3316 | Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3316 | Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3316 | Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3317 | Maxi Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3317 | Maxi Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3317 | Maxi Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 11822-3317 | Maxi Nicotine | nicotine polacrilex | Rite Aid Corporation | ANDA | Current |
| 46122-732 | Nicotine | nicotine polacrilex | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | Current |
| 46122-734 | Nicotine | nicotine polacrilex | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | Current |
| 69842-858 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-858 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-858 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-858 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-858 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-957 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-957 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-957 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-957 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 69842-957 | Nicotine | nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 70000-0561 | Maxi Nicotine | nicotine polacrilex | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0561 | Maxi Nicotine | nicotine polacrilex | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0561 | Maxi Nicotine | nicotine polacrilex | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0562 | Nicotine | nicotine polacrilex | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0562 | Nicotine | nicotine polacrilex | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0562 | Nicotine | nicotine polacrilex | Cardinal Health (Leader) 70000 | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54892 | ORIG | 2018-07-16 |