Application 076421

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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 43.

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
A076421-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28
A076421-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28
A076421-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076421-001	AB
A076421-002	AB
A076421-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076421-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076421-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076421-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076421-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076421-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076421-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076421-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076421-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076421-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076421-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076421-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076421-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076421-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076421-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076421-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076421-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076421-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076421-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076421-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076421-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076421-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076421-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076421-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076421-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076421-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076421-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076421-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076421-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076421-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076421-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076421-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076421-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076421-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076421-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076421-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076421-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076421-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076421-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076421-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076421-001	AB	1	`301d65b070ca…`

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	2028149f-6fc0-455c-bac5-729eeaa4aee5	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE TABLET	ANI Pharmaceuticals, Inc.	5a12889a-52ce-4dc4-9240-22d126f071ac	2025-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	bf810a3b-1a71-4a05-bf54-d5a6caba444b	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Hikma Pharmaceuticals USA Inc.	4f6b78d4-8ac8-464b-bb78-ee70cbc97898	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	475a52a9-f18c-4a69-91f0-8f5e601f4336	2024-11-13	Boxed warning, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Chartwell RX, LLC	a604aee4-30d5-4007-9882-98137d0d867f	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Amneal Pharmaceuticals LLC	d462d58e-fc3c-4c92-a210-e135eb1f4b77	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Proficient Rx LP	ee590951-cce8-4a1e-b3bd-ae0b610ebda9	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	6b73e32f-851b-4503-8296-e5db3a584b75	2024-05-24	Boxed warning, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	2013e6ef-9141-42c3-8ea8-285840ecdd15	2024-04-03	Boxed warning, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	5d6a4772-663e-468d-a8e1-4085e1b32bf7	2024-04-03	Boxed warning, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Aurobindo Pharma Limited	14e89448-3a18-42e3-8537-2589be1ef94e	2024-01-09	Boxed warning, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Rising Pharma Holdings, Inc.	e56335c1-5508-4136-bd2e-18385623e497	2024-01-09	Boxed warning, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	179e3821-0342-4b84-96bb-3fcab213d74f	2023-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	5dc5b522-f16f-4b3b-b325-f4ace495f966	2023-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
63304-794	Flecainide Acetate	Flecainide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-795	Flecainide Acetate	Flecainide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-796	Flecainide Acetate	Flecainide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current