Application 206394

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 2MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206394-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2016-12-15

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 2 · 43 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	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`f41ea6bd6efb…`

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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	cb306cdf-bab5-4b13-986b-21ade4764f00	2026-02-12	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	886c594f-4ff6-46e1-a992-cc6ec033db3a	2026-01-27	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394 ndc (product): 41250-529
BLIP	NICOTINE POLACRILEX	Blip Products, Inc.	2f829466-f2fb-43f1-9e82-0d33b50b913a	2025-03-17	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
good sense nicotine	NICOTINE POLACRILEX	A-S Medication Solutions	af4323b6-5240-4697-992a-512c4d098340	2024-05-15	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394

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 · 74 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0704	basic care nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-0704	basic care nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-0704	basic care nicotine	Nicotine polacrilex	L. Perrigo Company	ANDA	Current
0363-1012	nicotine	Nicotine polacrilex	Walgreen Company	ANDA	Current
0363-1012	nicotine	Nicotine polacrilex	Walgreen Company	ANDA	Current
0363-1012	nicotine	Nicotine polacrilex	Walgreen Company	ANDA	Current
0363-7269	NICOTINE	nicotine polacrilex	Walgreen Company	ANDA	Current
0363-7269	NICOTINE	nicotine polacrilex	Walgreen Company	ANDA	Current
0363-7269	NICOTINE	nicotine polacrilex	Walgreen Company	ANDA	Current
11673-269	up and up nicotine	nicotine	Target Corporation	ANDA	Current
11673-269	up and up nicotine	nicotine	Target Corporation	ANDA	Current
11673-269	up and up nicotine	nicotine	Target Corporation	ANDA	Current
11673-411	up and up nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current
11673-411	up and up nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current
11673-411	up and up nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current
11673-411	up and up nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current
11822-0269	nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-0269	nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-0904	nictoine gum	Nicotine polacrilex	Rite Aid Corporation	ANDA	Current
11822-0904	nictoine gum	Nicotine polacrilex	Rite Aid Corporation	ANDA	Current
11822-0904	nictoine gum	Nicotine polacrilex	Rite Aid Corporation	ANDA	Current
21130-186	signature care nicotine	Nicotine polacrilex	Safeway	ANDA	Current
21130-186	signature care nicotine	Nicotine polacrilex	Safeway	ANDA	Current
21130-269	signature care nicotine	nicotine	Safeway	ANDA	Current
21130-269	signature care nicotine	nicotine	Safeway	ANDA	Current
30142-208	Nicotine	Nicotine polacrilex	Kroger Company	ANDA	Current
30142-208	Nicotine	Nicotine polacrilex	Kroger Company	ANDA	Current
30142-208	Nicotine	Nicotine polacrilex	Kroger Company	ANDA	Current
30142-749	nicotine	nicotine polacrilex	Kroger Company	ANDA	Current
30142-749	nicotine	nicotine polacrilex	Kroger Company	ANDA	Current
30142-749	nicotine	nicotine polacrilex	Kroger Company	ANDA	Current
36800-269	topcare nicotine	nicotine polacrilex	Topco Associates LLC	ANDA	Current
36800-269	topcare nicotine	nicotine polacrilex	Topco Associates LLC	ANDA	Current
36800-269	topcare nicotine	nicotine polacrilex	Topco Associates LLC	ANDA	Current
36800-863	Topcare Nicotine Gum	Nicotine polacrilex	Topco Associates LLC	ANDA	Current
36800-863	Topcare Nicotine Gum	Nicotine polacrilex	Topco Associates LLC	ANDA	Current
37012-012	Nicotine	Nicotine polacrilex	Shopko Stores Operating Co., LLC	ANDA	Current
37012-012	Nicotine	Nicotine polacrilex	Shopko Stores Operating Co., LLC	ANDA	Current
37808-349	Nicotine	Nicotine polacrilex	H E B	ANDA	Current
37808-711	Nicotine	nicotine	H E B	ANDA	Current
37808-711	Nicotine	nicotine	H E B	ANDA	Current
37808-909	nicotine	nicotine polacrilex	H E B	ANDA	Current
37808-909	nicotine	nicotine polacrilex	H E B	ANDA	Current
41163-012	equaline nicotine	Nicotine polacrilex	Supervalu Inc	ANDA	Current
41163-012	equaline nicotine	Nicotine polacrilex	Supervalu Inc	ANDA	Current
41250-209	Nicotine	Nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-209	Nicotine	Nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-209	Nicotine	Nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-529	nicotine	nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-529	nicotine	nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-529	nicotine	nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41520-711	careone nicotine	Nicotine polacrilex	American Sales Company	ANDA	Current
41520-711	careone nicotine	Nicotine polacrilex	American Sales Company	ANDA	Current
42884-012	Zonnic nicotine	Nicotine polacrilex	Niconovum USA Inc.	ANDA	Current
49035-415	equate nicotine	nicotine polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-415	equate nicotine	nicotine polacrilex	Wal-Mart Stores Inc	ANDA	Current
63981-012	Kirkland Signature Quit 2	Nicotine polacrilex	Costco Wholesale Company	ANDA	Current
63981-012	Kirkland Signature Quit 2	Nicotine polacrilex	Costco Wholesale Company	ANDA	Current
63981-012	Kirkland Signature Quit 2	Nicotine polacrilex	Costco Wholesale Company	ANDA	Current
63981-012	Kirkland Signature Quit 2	Nicotine polacrilex	Costco Wholesale Company	ANDA	Current
68196-012	Members Mark Nicotine	Nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-012	Members Mark Nicotine	Nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-012	Members Mark Nicotine	Nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-012	Members Mark Nicotine	Nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-269	members mark nicotine	nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-269	members mark nicotine	nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-269	members mark nicotine	nicotine polacrilex	Sam's West Inc	ANDA	Current
68196-269	members mark nicotine	nicotine polacrilex	Sam's West Inc	ANDA	Current
68391-012	Berkley and Jensen NICOTINE	Nicotine polacrilex	BJWC	ANDA	Current
68391-012	Berkley and Jensen NICOTINE	Nicotine polacrilex	BJWC	ANDA	Current
68391-012	Berkley and Jensen NICOTINE	Nicotine polacrilex	BJWC	ANDA	Current
68391-012	Berkley and Jensen NICOTINE	Nicotine polacrilex	BJWC	ANDA	Current
70677-0169	sunmark nicotine	nicotine polacrilex	Strategic Sourcing Services LLC	ANDA	Current
72288-292	Basic Care Nicotine	Nicotine polacrilex	Amazon.com Services LLC	ANDA	Current