Application 207868

Type: ANDA
Sponsor: PLD ACQUISITIONS

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
A207868-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2019-02-07
A207868-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2019-02-07

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	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207868-001	PC	2019-10-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207868-002	PC	2019-10-01	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A207868-001	PC	2019-10-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207868-002	PC	2019-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207868-001	PC	2019-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207868-002	PC	2019-10-01	`b00525d2431f…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Mini	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ab184645-6fff-40cf-9859-4b8dec9098b2	2023-03-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 46122-715
Nicotine Mini	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ab1df1b4-a831-4de2-be87-38b9cd589db9	2023-03-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 46122-731
Nicotine Mini	NICOTINE POLACRILEX	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	4eeaf22c-a839-49c5-b099-77321d590d06	2022-12-06	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 49035-493
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	7fa848c6-3a4a-41f3-b927-1b26b6232e3a	2022-11-22	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 69842-564
Nicotine Mini	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	71ee5a44-b451-4ecd-9fe7-8124b4dae1c5	2022-10-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 70000-0560
Nicotine Mini	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	6edf8c50-d3b9-469a-ad57-37c05e098862	2022-10-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868 ndc (product): 70000-0559

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 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0262	Nicotine Mini	nicotine polacrilex	Walgreens	ANDA	Current
0363-0262	Nicotine Mini	nicotine polacrilex	Walgreens	ANDA	Current
0363-0262	Nicotine Mini	nicotine polacrilex	Walgreens	ANDA	Current
0363-2640	Mini Nicotine	nicotine polacrilex	Walgreens	ANDA	Current
0363-2640	Mini Nicotine	nicotine polacrilex	Walgreens	ANDA	Current
0363-2640	Mini Nicotine	nicotine polacrilex	Walgreens	ANDA	Current
0536-1239	Nicotine Mini	nicotine polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1239	Nicotine Mini	nicotine polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1239	Nicotine Mini	nicotine polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1241	Mini Nicotine	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1241	Mini Nicotine	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-1241	Mini Nicotine	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
11822-3315	Nicotine Mini	nicotine polacrilex	Rite Aid Corporation	ANDA	Current
11822-3315	Nicotine Mini	nicotine polacrilex	Rite Aid Corporation	ANDA	Current
11822-3622	Mini Nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3622	Mini Nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3622	Mini Nicotine	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
17856-1239	Nicotine Mini	nicotine polacrilex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1241	Mini Nicotine	Nicotine Polacrilex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
46122-715	Nicotine Mini	nicotine polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-716	Mini Nicotine	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-716	Mini Nicotine	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-731	Nicotine Mini	nicotine polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
49035-436	Mini Nicotine	Nicotine Polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-493	Nicotine Mini	nicotine polacrilex	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ANDA	Current
49035-493	Nicotine Mini	nicotine polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-493	Nicotine Mini	nicotine polacrilex	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
59726-262	Nicotine Mini	nicotine polacrilex	P & L Development, LLC	ANDA	Current
59726-262	Nicotine Mini	nicotine polacrilex	P & L Development, LLC	ANDA	Current
59726-262	Nicotine Mini	nicotine polacrilex	P & L Development, LLC	ANDA	Current
63548-0262	Nicotine	nicotine polacrilex	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0262	Nicotine	nicotine polacrilex	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0264	Nicotine	nicotine polacrilex	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0264	Nicotine	nicotine polacrilex	PLD Acquisitions LLC DBA Av	ANDA	Current
68016-086	Mini Nicotine	nicotine polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-086	Mini Nicotine	nicotine polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-087	Mini Nicotine	nicotine polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-087	Mini Nicotine	nicotine polacrilex	Chain Drug Consortium, LLC	ANDA	Current
69842-564	Nicotine	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-564	Nicotine	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-564	Nicotine	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-662	Nicotine	nicotine polacrilex	CVS Pharmacy	ANDA	Current
69842-662	Nicotine	nicotine polacrilex	CVS Pharmacy	ANDA	Current
69842-662	Nicotine	nicotine polacrilex	CVS Pharmacy	ANDA	Current
70000-0559	Nicotine Mini	nicotine polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0559	Nicotine Mini	nicotine polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0559	Nicotine Mini	nicotine polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0560	Nicotine Mini	nicotine polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0560	Nicotine Mini	nicotine polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0560	Nicotine Mini	nicotine polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
79903-127	Nicotine Mini	nicotine polacrilex	WALMART INC. (see also Equate)	ANDA	Current
79903-127	Nicotine Mini	nicotine polacrilex	WALMART INC. (see also Equate)	ANDA	Current
79903-127	Nicotine Mini	nicotine polacrilex	WALMART INC. (see also Equate)	ANDA	Current
79903-128	Mini Nicotine	Nicotine Polacrilex	WALMART INC. (see also Equate)	ANDA	Current
79903-128	Mini Nicotine	Nicotine Polacrilex	WALMART INC. (see also Equate)	ANDA	Current
79903-128	Mini Nicotine	Nicotine Polacrilex	WALMART INC. (see also Equate)	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71474	ORIG	2022-06-28