Application 077007
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
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 |
|---|---|---|---|---|---|---|---|
| A077007-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | ||
| A077007-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 |
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.
| 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 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 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 | Rite Aid Corporation | 09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9 | 2026-09-09 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Rite Aid Corporation | c94d46b1-f526-4af0-8f7c-8261b9ed6841 | 2026-09-09 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Sixarp, LLC | 5a94092b-f80e-c656-e063-6294a90ab15a | 2026-09-03 | Warnings | 077007 ANDA077007 |
| QUITINE NICOTINE | NICOTINE POLACRILEX | QUITINE LLC | 2e24f6d7-957e-4c7c-a486-8a1c1b47d53f | 2026-08-31 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | 8430a12b-4a7b-48a1-aa8f-7e55c5fde3c0 | 2026-08-28 | Warnings | 077007 ANDA077007 |
| NICOTINE | NICOTINE POLACRILEX | Walgreen Company | 5dd116ea-d031-439c-b06c-2f77230bc446 | 2026-08-20 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | e40a534e-8083-454d-9667-826bfbac397c | 2026-08-19 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | bc1b6b41-d069-470e-90ca-a441ab97f96a | 2026-08-18 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 9ba85e0a-bcb7-4803-8d21-0eb93768cb3a | 2026-08-07 | Warnings | 077007 ANDA077007 |
| Quitine Nicotine | NICOTINE POLACRILEX | QUITINE LLC | 4cc32b8c-6316-4d4b-8fa9-ef640464ca69 | 2026-08-06 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Publix Super Markets Inc | 00b40bb3-3785-4a53-804e-633795e87f71 | 2026-07-20 | Warnings | 077007 ANDA077007 |
| EQUATE NICOTINE | NICOTINE POLACRILEX | WALMART INC. | b6379f86-1528-465d-9527-bd2fead0068f | 2026-07-15 | Warnings | 077007 ANDA077007 |
| Good Sense Nicotine | NICOTINE POLACRILEX | L. Perrigo Company | 5c89061b-1452-4962-9f25-212f2ae8e41e | 2026-07-13 | Warnings | 077007 ANDA077007 |
| nicotine coated | NICOTINE POLACRILEX | Publix Super Markets Inc | a0113a1d-3691-4f18-9950-ae6d8d7d19ea | 2026-07-10 | Warnings | 077007 ANDA077007 |
| NICOTINE | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0ef9e55d-83e0-4ba5-a905-8cddb0db0019 | 2026-07-09 | Warnings | 077007 ANDA077007 |
| nicotine coated | NICOTINE POLACRILEX | Publix Super Markets Inc | 8cb5577b-48c0-47f8-8979-0ab54d713045 | 2026-07-09 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | Kroger Company | 35f45900-af2e-4b74-9772-8beb55236457 | 2026-06-26 | Warnings | 077007 ANDA077007 |
| quitine nicotine | NICOTINE POLACRILEX | QUITINE LLC | 21014e98-2c7c-4cc6-8595-a717910710a4 | 2026-06-26 | Warnings | 077007 ANDA077007 |
| quitine nicotine | NICOTINE POLACRILEX | QUITINE LLC | fd9ce0e2-b159-4e0d-a76e-7223d36810fb | 2026-06-26 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | Kroger Company | 0ef57432-471d-4c7a-b8be-0f898f01d197 | 2026-06-26 | Warnings | 077007 ANDA077007 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55301-873 | exchange select nicotine | Nicotine Polacrilex | Army & Air Force Exchange Service | ANDA | Current |
| 55301-873 | exchange select nicotine | Nicotine Polacrilex | Army & Air Force Exchange Service | ANDA | Current |
| 55316-344 | Healthy Accents Nicotine | Nicotine Polacrilex | DZA Brands LLC | ANDA | Current |
| 56062-344 | stop smoking aid | Nicotine Polacrilex | Publix Super Markets Inc | ANDA | Current |
| 56062-344 | stop smoking aid | Nicotine Polacrilex | Publix Super Markets Inc | ANDA | Current |
| 56062-873 | stop smoking aid | Nicotine Polacrilex | Publix Super Markets Inc | ANDA | Current |
| 56062-873 | stop smoking aid | Nicotine Polacrilex | Publix Super Markets Inc | ANDA | Current |
| 59779-344 | Nicotine | Nicotine Polacrilex | CVS Pharmacy | ANDA | Current |
| 59779-344 | Nicotine | Nicotine Polacrilex | CVS Pharmacy | ANDA | Current |
| 59779-344 | Nicotine | Nicotine Polacrilex | CVS Pharmacy | ANDA | Current |
| 59779-873 | nicotine | Nicotine polacrilex | CVS Pharmacy | ANDA | Current |
| 62011-0048 | health mart nicotine polacrilex | Nicotine Polacrilex | McKesson | ANDA | Current |
| 62011-0048 | health mart nicotine polacrilex | Nicotine Polacrilex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0048 | health mart nicotine polacrilex | Nicotine Polacrilex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0171 | health mart nicotine polacrilex | Nicotine Polacrilex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0171 | health mart nicotine polacrilex | Nicotine Polacrilex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0171 | health mart nicotine polacrilex | Nicotine Polacrilex | McKesson | ANDA | Current |
| 63981-344 | kirkland signature quit 2 | Nicotine Polacrilex | Costco Wholesale Company | ANDA | Current |
| 63981-873 | kirkland signature quit 4 | Nicotine Polacrilex | Costco Wholesale Company | ANDA | Current |
| 68196-082 | members mark nicotine | Nicotine Polacrilex | Sam's West Inc | ANDA | Current |
| 68196-082 | members mark nicotine | Nicotine Polacrilex | Sam's West Inc | ANDA | Current |
| 68196-082 | members mark nicotine | Nicotine Polacrilex | Sam's West Inc | ANDA | Current |
| 68196-873 | Members Mark Nicotine | Nicotine Polacrilex | Sam's West Inc | ANDA | Current |
| 68196-873 | Members Mark Nicotine | Nicotine Polacrilex | Sam's West Inc | ANDA | Current |
| 68258-7991 | Good Sense Nicotine | Nicotine Polacrilex | Dispensing Solutions, Inc. | ANDA | Current |
| 68258-7992 | good sense nicotine | Nicotine Polacrilex | Dispensing Solutions, Inc. | ANDA | Current |
| 68391-344 | berkley and jensen nicotine | Nicotine Polacrilex | BJWC | ANDA | Current |
| 68391-873 | berkley and jensen nicotine polacrilex | Nicotine Polacrilex | BJWC | ANDA | Current |
| 70000-0349 | Leader Nicotine | Nicotine Polacrilex | Cardinal Health | ANDA | Current |
| 70000-0349 | Leader Nicotine | Nicotine Polacrilex | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0350 | leader nicotine | Nicotine Polacrilex | Cardinal Health | ANDA | Current |
| 70000-0350 | leader nicotine | Nicotine Polacrilex | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 72288-344 | basic care nicotine | Nicotine Polacrilex | Amazon.com Services LLC | ANDA | Current |
| 72288-492 | basic care nicotine | Nicotine Polacrilex | Amazon.com Services LLC | ANDA | Current |
| 72288-873 | basic care nicotine | Nicotine Polacrilex | Amazon.com Services LLC | ANDA | Current |
| 72288-873 | basic care nicotine | Nicotine Polacrilex | Amazon.com Services LLC | ANDA | Current |
| 72288-873 | basic care nicotine | Nicotine Polacrilex | Amazon.com Services Inc. | ANDA | Current |
| 72288-873 | basic care nicotine | Nicotine Polacrilex | Amazon.com Services LLC | ANDA | Current |
| 79903-101 | euqate nicotine | Nicotine Polacrilex | WALMART INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31185 | ORIG | 2006-02-02 |