Application 215357

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 42.

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
A215357-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2022-05-13
A215357-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2022-05-13

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 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`a72a2bbeb626…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	5102e242-4d27-4b1f-8a65-2b52ba3f2276	2025-05-14	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 58602-854
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX MINI	Amazon.com Services LLC	113e54e3-e9c3-4949-e063-6394a90a6fdf	2025-05-02	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX MINI	Amazon.com Services LLC	10ee6816-8155-d590-e063-6394a90a9dea	2025-05-02	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	169c7976-f865-4716-953d-383e435d67c5	2024-06-20	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 58602-855
NICOTINE	NICOTINE POLACRILEX MINI	BLIP PRODUCTS, INC.	e88c8815-4d38-3a59-e053-2995a90afc82	2023-08-11	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 82966-001
NICOTINE	NICOTINE POLACRILEX MINI	BLIP PRODUCTS, INC.	eb714022-332d-5c6f-e053-2a95a90a75c9	2023-08-11	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 82966-002
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	85f05cc6-ae2e-4338-8c1e-c681c2f90858	2022-11-03	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 58602-723
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	cfe6fb63-2897-4e76-8288-1389f363b3c4	2022-11-03	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 58602-722

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58602-722	NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	ANDA	Current
58602-723	NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	ANDA	Current
58602-854	NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	ANDA	Current
58602-855	NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	ANDA	Current
82966-001	NICOTINE	NICOTINE POLACRILEX MINI	BLIP PRODUCTS, INC.	ANDA	Current
82966-002	NICOTINE	NICOTINE POLACRILEX MINI	BLIP PRODUCTS, INC.	ANDA	Current