Application 203690

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	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
A203690-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2012-10-09
A203690-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2012-10-09

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	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`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 5 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care nicotine	NICOTINE POLACRILEX	Safeway	22010ed8-7fa6-402a-a314-523538183a55	2018-11-01	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690 ndc (product): 21130-172
signature care nicotine	NICOTINE POLACRILEX	Safeway	664c3faf-7cab-4bda-8987-07acb8e1142b	2018-10-31	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690 ndc (product): 21130-185
exchange select nicotine	NICOTINE POLACRILEX	Army & Air Force Exchange Service	e926cf6f-305a-4912-be07-a45bb7905822	2018-09-21	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	357123fc-0972-4683-ab52-f95d46c1b6c9	2017-11-09	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690

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 2 · 146 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0734	Good Sense Nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-0957	Good Sense Nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-6000	Tru Relief Nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-6001	Tru Relief Nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-7007	basic care nicotine	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-7008	basic care nicotine	nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-7201	Basic Care nicotine	nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-7203	Basic Care nicotine	nicotine polacrilex	L. Perrigo Company	ANDA	Current
0113-7734	basic care nicotine mini	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-7734	basic care nicotine mini	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-7957	basic care nicotine mini	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0113-7957	basic care nicotine mini	Nicotine Polacrilex	L. Perrigo Company	ANDA	Current
0363-0734	nicotine mini	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0957	Nicotine mini	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-1130	nicotine mini	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-1130	nicotine mini	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-1130	nicotine mini	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-1825	nicotine	nicotine polacrilex	Walgreen Company	ANDA	Current
0363-1825	nicotine	nicotine polacrilex	Walgreen Company	ANDA	Current
0363-1825	nicotine	nicotine polacrilex	Walgreen Company	ANDA	Current
11673-734	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-734	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-734	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-734	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-858	up and up mini nicotine	nicotine polacrilex	Target Corporation	ANDA	Current
11673-879	up and up mini nicotine	nicotine	Target Corporation	ANDA	Current
11673-881	up and up mini nicotine polacrilex	nicotine	Target Corporation	ANDA	Current
11673-953	up and up mini nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-957	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-957	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-957	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11673-957	Up and Up Nicotine	Nicotine Polacrilex	Target Corporation	ANDA	Current
11822-0734	Nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-0957	Mini Nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-1007	nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3802	nicotine	nicotine polacrilex	Rite Aid Corporation	ANDA	Current
21130-172	signature care nicotine	Nicotine Polacrilex	Safeway	ANDA	Current
21130-185	signature care nicotine	Nicotine Polacrilex	Safeway	ANDA	Current
30142-060	Nicotine Mini	Nicotine Polacrilex	Kroger Company	ANDA	Current
30142-060	Nicotine Mini	Nicotine Polacrilex	Kroger Company	ANDA	Current
30142-209	Nicotine Mini	Nicotine Polacrilex	Kroger Company	ANDA	Current
30142-209	Nicotine Mini	Nicotine Polacrilex	Kroger Company	ANDA	Current
30142-696	nicotine	nicotine polacrilex	Kroger Company	ANDA	Current
30142-797	nicotine	nicotine polacrilex	Kroger Company	ANDA	Current
30142-957	Nicotine	Nicotine Polacrilex	Kroger Company	ANDA	Current
36800-734	Topcare Nicotine	Nicotine Polacrilex	Topco Associates LLC	ANDA	Current
36800-734	Topcare Nicotine	Nicotine Polacrilex	Topco Associates LLC	ANDA	Current
36800-957	Topcare Nicotine	Nicotine Polacrilex	Topco Associates LLC	ANDA	Current
36800-957	Topcare Nicotine	Nicotine Polacrilex	Topco Associates LLC	ANDA	Current
37012-803	nicotine mini	Nicotine Polacrilex	Shopko Stores Operating Co., LLC	ANDA	Current
37012-957	nicotine mini	Nicotine Polacrilex	Shopko Stores Operating Co., LLC	ANDA	Current
37808-563	nicotine	Nicotine Polacrilex	H E B	ANDA	Current
37808-617	nicotine	nicotine polacrilex	H E B	ANDA	Current
37808-707	Nicotine	nicotine	H E B	ANDA	Current
37808-734	in control nicotine	Nicotine Polacrilex	H E B	ANDA	Current
37808-900	Nicotine	nicotine	H E B	ANDA	Current
37808-957	in control nicotine	Nicotine Polacrilex	H E B	ANDA	Current
41250-587	mini nicotine	nicotine polacrilex	Meijer Distribution Inc	ANDA	Current
41250-637	mini nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-734	Nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-734	Nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-957	Nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41250-957	Nicotine	Nicotine Polacrilex	Meijer Distribution Inc	ANDA	Current
41520-734	CareOne Nicotine	Nicotine Polacrilex	American Sales Company	ANDA	Current
41520-957	CareOne Mini Nicotine Polacrilex	Nicotine Polacrilex	American Sales Company	ANDA	Current
42884-734	Zonnic Nicotine Mini	Nicotine Polacrilex	Niconovum USA Inc.	ANDA	Current
42884-957	zonnic	Nicotine Polacrilex	Niconovum USA Inc.	ANDA	Current
45802-089	Nicotine Polacrilex	Nicotine Polacrilex	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-089	Nicotine Polacrilex	Nicotine Polacrilex	Perrigo New York Inc	ANDA	Current
45802-957	Nicotine Polacrilex	Nicotine Polacrilex	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-957	Nicotine Polacrilex	Nicotine Polacrilex	Perrigo New York Inc	ANDA	Current
46122-254	Good Neighbor Pharmacy Nicotine	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
46122-255	good neighbor pharmacy nicotine mini	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
46122-663	good neighbor pharmacy nicotine	nicotine polacrilex	Amerisource Bergen	ANDA	Current
46122-665	good neighbor pharmacy nicotine mini	Nicotine Polacrilex	Amerisource Bergen	ANDA	Current
49035-734	Equate Nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-734	Equate Nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-734	Equate Nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-791	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current
49035-791	equate nicotine	Nicotine Polacrilex	Wal-Mart Stores Inc	ANDA	Current