Application 209520

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
A209520-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2019-10-31
A209520-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2019-10-31

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.

Product history page 1 of 3 · 82 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	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209520-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209520-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`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.

Matched openFDA labels page 22 of 26 · 506 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLIP	NICOTINE POLACRILEX	Blip Products, Inc.	2f829466-f2fb-43f1-9e82-0d33b50b913a	2025-03-17	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	McKesson Corporation dba SKY Packaging	0b6880c8-04e7-418a-98d1-0c7d19e025b3	2025-03-06	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Maxi Nicotine	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	362b4a04-4a5f-4af6-9cd7-82aa172b7afb	2025-02-26	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	The Kroger Co.	8c81c885-1d56-4dca-b9bc-adfc9bf58051	2025-02-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	9b1d9efc-f74b-42f5-be84-5142ee168767	2025-01-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	7f1cdc21-d213-4ede-86fd-e11b31dfab58	2025-01-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Padagis Israel Pharmaceuticals Ltd	157e5479-28d6-4493-a8cf-597b9e5622c0	2025-01-14	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Quitine LLC	dc142c50-5310-43f5-a9e5-e174116685f8	2024-12-17	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Quitine LLC	9e46b967-1668-42a7-be87-225ded849395	2024-12-17	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	CVS Pharmacy	e4e3fd5f-1ed1-4a18-9c31-7224cae77ded	2024-10-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine mini	NICOTINE POLACRILEX	Walgreen Company	4a08b910-5479-49f5-abbe-ca68949efb24	2024-08-22	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicorette Original	NICOTINE POLACRILEX	Haleon US Holdings LLC	673fd19f-69b3-4f73-b9b4-18b5f4cbf69c	2024-08-13	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicorette Fruit Chill	NICOTINE POLACRILEX	Haleon US Holdings LLC	a0206139-59c6-44c3-963c-8cb5f2d69075	2024-07-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2	2024-07-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICOTINE	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	114418c4-6f39-46ce-912c-ac3687b7b75e	2024-07-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
good sense nicotine	NICOTINE POLACRILEX	L. Perrigo Company	ee345181-4999-4948-9589-7d70d61885ad	2024-06-18	Warnings	Name fallback generic name: NICOTINE POLACRILEX
good sense nicotine	NICOTINE POLACRILEX	A-S Medication Solutions	af4323b6-5240-4697-992a-512c4d098340	2024-05-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
nicotine	NICOTINE POLACRILEX	CVS Pharmacy	a7348e93-bc5d-48d8-b2a4-daf921343d44	2024-05-08	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up cherry nicotine	NICOTINE POLACRILEX	Target Corporation	85d82812-9f90-401f-8a2c-729cbfdf4c78	2024-03-29	Warnings	Name fallback generic name: NICOTINE POLACRILEX
up and up mint nicotine	NICOTINE POLACRILEX	Target Corporation	740833d6-5406-4609-9d14-bd5c9072fe9a	2024-03-28	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55244	ORIG	2018-08-20