Application 078697

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	GUM, CHEWING;BUCCAL	EQ 4MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078697-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2008-12-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`cb3db0bc1861…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories	621eb214-0716-4306-829f-6185a77f24d5	2026-07-16	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 0536-3113
Nicotine Polacrilex coated mint	NICOTINE POLACRILEX	CVS Pharmacy	84daeb67-5982-4b9e-b56a-4cc6a223a3f8	2026-05-05	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 69842-430
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	2c420ee4-0ed0-4a3f-bc92-202d825d0ca3	2026-04-13	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 70000-0343
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	b4ac0a22-3556-4591-aa7b-e09c6010adc8	2026-03-26	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 68016-560 ndc (product): 68016-281 ndc (product): 68016-285
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	826f63b2-fd18-4213-be38-a430d78897cb	2026-03-25	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 0363-9330
Nicotine Polacrilex	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	53c82cf8-d97b-4a5a-a357-fb74a74d1ef3	2026-03-18	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 46122-718
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	a6ef9fd0-9706-4924-b7f5-e2562b9d99e0	2026-02-23	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 56062-429
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	ed5722d7-746b-468e-89b5-506055d12bbd	2025-12-23	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	2025-12-06	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	27308f6b-43b9-4b1d-af6b-7a39b79def03	2025-05-08	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 55301-429
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	b97d27d2-a6e1-40da-bdc2-eaf7b88321f6	2025-04-29	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4af800f9-bcb3-4320-8d32-f1bfd54ee5e9	2025-04-03	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Quitine LLC	dc142c50-5310-43f5-a9e5-e174116685f8	2024-12-17	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5b30fa5a-fff7-46ec-9f33-fda633cc315d	2024-11-06	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0429	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-0429	Nicotine	Nicotine Polacrilex	Walgreen Company	ANDA	Current
0363-9330	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9330	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9330	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9330	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0363-9330	Nicotine Polacrilex	Nicotine Polacrilex	Walgreens	ANDA	Current
0536-3113	Rugby Nicotine Polacrilex Gum, Coated Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3113	Rugby Nicotine Polacrilex Gum, Coated Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3113	Rugby Nicotine Polacrilex Gum, Coated Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3113	Rugby Nicotine Polacrilex Gum, Coated Mint Flavor	Nicotine Polacrilex	Rugby Laboratories, Inc.	ANDA	Current
0536-3113	Rugby Nicotine Polacrilex Gum, Coated Mint Flavor	Nicotine Polacrilex	Rugby Laboratories	ANDA	Current
11822-3326	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
11822-3326	Nicotine Polacrilex	Nicotine Polacrilex	Rite Aid Corporation	ANDA	Current
46122-718	Nicotine Polacrilex	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-718	Nicotine Polacrilex	Nicotine Polacrilex	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
55301-429	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
55301-429	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
55301-429	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
55301-429	Nicotine Polacrilex	Nicotine Polacrilex	Army and Air Force Exchange Service	ANDA	Current
55301-429	Nicotine Polacrilex	Nicotine Polacrilex	AAFES/Your Military Exchanges	ANDA	Current
56062-429	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-429	Nicotine Polacrilex	Nicotine Polacrilex	Publix	ANDA	Current
56062-429	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-429	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
56062-429	Nicotine Polacrilex	Nicotine Polacrilex	Publix	ANDA	Current
56062-429	Nicotine Polacrilex	Nicotine Polacrilex	Publix Supermarkets, Inc.	ANDA	Current
63868-167	Nicotine Polacrilex	Nicoitne Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-167	Nicotine Polacrilex	Nicoitne Polacrilex	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-167	Nicotine Polacrilex	Nicoitne Polacrilex	Chain Drug Marketing Association Inc.	ANDA	Current
63868-193	Nicotine Polacrilex, Coated Mint Flavor	Nicotine Polacrilex	Chain Drug Marketing Association Inc.	ANDA	Current
66715-9803	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9803	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9803	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9803	Nicotac Nicotine Polacrilex	Nicotine	Lil' Drug Store Products, Inc.	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-281	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-285	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
68016-560	Nicotine Polacrilex	Nicotine Polacrilex	Chain Drug Consortium, LLC	ANDA	Current
69842-430	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-430	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-430	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-430	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-430	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
69842-430	Nicotine Polacrilex	Nicotine Polacrilex	CVS Pharmacy	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health, Inc.	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
70000-0343	Nicotine Polacrilex	Nicotine Polacrilex	Cardinal Health (Leader) 70000	ANDA	Current
72484-429	Nicotine Polacrilex	Nicotine Polacrilex	Roman Health Ventures Inc.	ANDA	Current
72484-429	Nicotine Polacrilex	Nicotine Polacrilex	Roman Health Ventures Inc.	ANDA	Current