Application 215599

Type: ANDA
Sponsor: YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	TABLET;ORAL	50MG	No	No
002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	TABLET;ORAL	100MG	No	No
003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	TABLET;ORAL	150MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215599-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08
A215599-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08
A215599-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215599-001	AB
A215599-002	AB
A215599-003	AB

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 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215599-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215599-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215599-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215599-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215599-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215599-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215599-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215599-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215599-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215599-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215599-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215599-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215599-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE	Epic Pharma, LLC	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215599 application number: ANDA215599 ndc (product): 42806-817 ndc (product): 42806-819 ndc (product): 42806-818
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	8a900f29-85e1-464c-ae9e-44dc7cf11f46	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215599 application number: ANDA215599
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	5cfa10ba-dfe8-42ab-81b3-8cca657aba07	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215599 application number: ANDA215599
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	b821ec16-93ff-4569-9fbb-4f3842c58bec	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215599 application number: ANDA215599

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-817	Flecainide Acetate	flecainide acetate	Epic Pharma, LLC	ANDA	Current
42806-818	Flecainide Acetate	flecainide acetate	Epic Pharma, LLC	ANDA	Current
42806-819	Flecainide Acetate	flecainide acetate	Epic Pharma, LLC	ANDA	Current