Application 076278

Type: ANDA
Sponsor: HIKMA

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	Yes

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	RLD / RS	Approval date
A076278-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14
A076278-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14
A076278-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076278-001	AB
A076278-002	AB
A076278-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076278-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB		2003-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076278-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	RS	2003-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076278-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB		2003-01-14	`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	A076278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076278-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076278-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076278-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076278-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076278-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076278-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076278-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076278-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076278-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076278-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076278-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076278-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076278-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076278-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076278-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076278-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076278-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076278-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076278-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076278-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076278-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076278-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076278-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076278-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076278-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076278-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076278-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076278-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076278-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076278-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE	Hikma Pharmaceuticals USA Inc.	4f6b78d4-8ac8-464b-bb78-ee70cbc97898	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076278 application number: ANDA076278 ndc (product): 0054-0012 ndc (product): 0054-0011 ndc (product): 0054-0010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0010	Flecainide Acetate	flecainide acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0011	Flecainide Acetate	flecainide acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0012	Flecainide Acetate	flecainide acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0179-0201	Flecainide Acetate	flecainide acetate	KAISER FOUNDATION HOSPITALS	ANDA	Current
50090-1132	Flecainide Acetate	flecainide acetate	A-S Medication Solutions	ANDA	Current
50090-1132	Flecainide Acetate	flecainide acetate	A-S Medication Solutions	ANDA	Current
68151-1464	Flecainide Acetate	flecainide acetate	Carilion Materials Management	ANDA	Current