Application 075442

Type: ANDA
Sponsor: AMNEAL PHARM

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
A075442-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31
A075442-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31
A075442-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075442-001	AB
A075442-002	AB
A075442-003	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 4 · 123 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	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A075442-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075442-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075442-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075442-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075442-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075442-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075442-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075442-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075442-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075442-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075442-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075442-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075442-001	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	AvPAK	f53e1a49-6185-6db4-c867-ffd1241a8cb7	2026-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442 ndc (product): 50268-321 ndc (product): 50268-322 ndc (product): 50268-320
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	166aa9e4-3402-4ebd-baa5-07a8da8aae56	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442
Flecainide Acetate	FLECAINIDE ACETATE	Amneal Pharmaceuticals LLC	d462d58e-fc3c-4c92-a210-e135eb1f4b77	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442 ndc (product): 65162-642 ndc (product): 65162-643 ndc (product): 65162-641
Flecainide Acetate	FLECAINIDE ACETATE	Amneal Pharmaceuticals of New York LLC	ee9595d5-08a1-4529-9215-ddc3c7f929c4	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442 ndc (product): 53746-642 ndc (product): 53746-641 ndc (product): 53746-643

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-293	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-293	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-293	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-294	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-294	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-294	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-295	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
42291-295	Flecainide Acetate	Flecainide Acetate	AvKARE, Inc.	ANDA	Current
50090-1133	Flecainide Acetate	Flecainide Acetate	A-S Medication Solutions	ANDA	Current
50268-320	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
50268-320	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
50268-320	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
50268-321	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
50268-321	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
50268-321	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
50268-322	Flecainide Acetate	Flecainide Acetate	AvPAK	ANDA	Current
53746-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals of New York LLC	ANDA	Current
60687-225	Flecainide Acetate	Flecainide Acetate	American Health Packaging	ANDA	Current
65162-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-641	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-642	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-643	Flecainide Acetate	Flecainide Acetate	Amneal Pharmaceuticals LLC	ANDA	Current
68084-540	Flecainide Acetate	Flecainide Acetate	American Health Packaging	ANDA	Current