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 10 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mini Nicotine	NICOTINE POLACRILEX	Walgreens	dfdd100d-8808-40f4-a68e-1e0388be424d	2026-05-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreen Company	77688e56-4293-4f37-9f48-fe09267ff619	2026-05-07	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	Walgreens	60551e9a-c82f-45ce-8ef4-03c00c6c870a	2026-05-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex coated fruit	NICOTINE POLACRILEX	CVS Pharmacy	8c5e99d7-9d2d-488b-a804-496edafd30cf	2026-05-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreen Company	c44821ba-5c2a-4586-8210-afc02a4031d5	2026-05-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex coated mint	NICOTINE POLACRILEX	CVS Pharmacy	84daeb67-5982-4b9e-b56a-4cc6a223a3f8	2026-05-05	Warnings	Name fallback generic name: NICOTINE POLACRILEX
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	d146d768-b975-462c-bc94-c2132e1bdac7	2026-05-02	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Padagis Israel Pharmaceuticals Ltd	b765570e-e5b5-48e4-b4d2-2a85ac19a2ea	2026-04-30	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	0f1b3cc6-98df-4e34-91f3-dc251fe170f8	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	9d315243-b55e-4277-b0c2-83e7b5fe504c	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	e808dd98-3307-4dcf-b042-910ea6c3170a	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	b5d5bdb5-8961-4c8a-9f58-4f23044264a6	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	dc4d4fe1-6a60-4f02-b04f-a500e22d25da	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Walgreen Company	59afdc0a-5e45-4cca-abef-4415c170a19a	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	Walgreen Company	7446369d-2fac-4c5a-a6bb-9e149abc4c15	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	f5f813aa-80f5-410c-9b16-416e955c02a9	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	1c49ddd3-0f2c-4310-acf1-edd42e3aafc5	2026-04-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up coated cool mint nicotine	NICOTINE POLACRILEX	Target Corporation	7b5e2b0d-0c29-4cdf-acb0-a202bdb7463c	2026-04-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Foster and Thrive Nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	23d8c1a7-a1e4-488d-bc66-b22683abf08b	2026-04-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up coated cinnamon nicotine	NICOTINE POLACRILEX	Target Corporation	8e8884c9-69cb-424c-8ed0-ebd66d5bb175	2026-04-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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