Application 209519

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 43.

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
A209519-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2018-07-02
A209519-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2018-07-02

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209519-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209519-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-07-02	`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.

Matched openFDA labels page 1 of 27 · 522 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	da4c5203-76d7-454f-85bd-1717d95506bd	2026-09-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9	2026-09-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	c94d46b1-f526-4af0-8f7c-8261b9ed6841	2026-09-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	ae802de5-8e1b-439f-ab81-db4bd7241c91	2026-09-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	HC Jones, Inc.	d0d1a5ef-fd4c-4854-9453-68808cc0fab0	2026-09-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	HC Jones, Inc.	e07226e8-3be4-46e4-aa4f-c5d88db1ccfa	2026-09-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Sixarp, LLC	5a94092b-f80e-c656-e063-6294a90ab15a	2026-09-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	HC Jones, Inc.	80e9ee49-2b38-4b59-80a7-524021bf2b21	2026-09-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	Amazon.com Services LLC	ec341a77-5b62-4980-8d31-27c12ae92561	2026-09-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	HC Jones, Inc.	ff9e34ff-5086-4e1b-9220-27ac2ac1069c	2026-09-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex Original Flavor	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	540c88bd-70dc-416a-8d8e-0a33b2b29563	2026-09-02	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up citrus mini nicotine	NICOTINE POLACRILEX	Target Corporation	7457f30e-0281-49db-91e0-ddaedaa6b257	2026-09-01	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE MINI	NICOTINE POLACRILEX	Amazon.com Services LLC	d6f7dea2-6375-4057-8947-314a429fa492	2026-09-01	Warnings	Name fallback generic name: NICOTINE POLACRILEX
QUITINE NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	2e24f6d7-957e-4c7c-a486-8a1c1b47d53f	2026-08-31	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	8430a12b-4a7b-48a1-aa8f-7e55c5fde3c0	2026-08-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	a1c85adc-8b42-40ad-91b4-0bf92a6341a5	2026-08-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Bryant Ranch Prepack	b2f4506b-b575-4ed8-b10b-935451ea3451	2026-08-27	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Bryant Ranch Prepack	a3ca2479-9703-41de-918a-881da16e5c98	2026-08-27	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Padagis Israel Pharmaceuticals Ltd	f6cc8d50-2d8d-4ed4-930a-a2479b1ebffe	2026-08-27	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreens	d933d32c-cb4a-41b2-9563-da74cf2d77e4	2026-08-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.