Application 209206

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 44.

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
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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`3a93d1ddd44b…`

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 46122-734
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	39640129-2d7a-4ec5-81a1-e14b11d3d3ee	2026-03-12	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 46122-732
Nicotine	NICOTINE POLACRILEX	Walgreens	25dc2032-4e6a-440a-8327-7b6c877a2430	2026-01-20	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 0363-9570
Nicotine	NICOTINE POLACRILEX	Walgreens	49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f4	2026-01-20	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 0363-9580
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	a275ff04-4078-4783-932b-dde9aee04682	2025-08-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 69842-858
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	63fce25d-457f-4048-86a4-1805f603936c	2025-08-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 69842-957
Maxi Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	1472b0a3-5ff1-44e7-8748-a3b1a5e55196	2025-08-25	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 11822-3317
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	150faf42-491f-403b-869b-48edd431d1cc	2025-07-18	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 0536-1337
Maxi Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	7c2e0872-75f6-4c4f-afff-3579375708de	2025-07-18	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 0536-1338
Maxi Nicotine	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	362b4a04-4a5f-4af6-9cd7-82aa172b7afb	2025-02-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 70000-0561

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
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 table
Document	Submission type	Date
54892	ORIG	2018-07-16