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 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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076421-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2003-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076421-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2003-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076421-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2003-03-28	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076421-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076421-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076421-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076421-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076421-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076421-001	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 2 · 35 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	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	a30103c5-a261-49a5-a7b3-f43eb77e87b7	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	abcb261b-30ae-4eb1-baf0-e9667a2bd8cf	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	2b336028-1e13-4ef7-b75e-345bc9c06f9a	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	45d39dff-22d9-4c04-af26-0cffd41abaa8	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	8a900f29-85e1-464c-ae9e-44dc7cf11f46	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	5cfa10ba-dfe8-42ab-81b3-8cca657aba07	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	b821ec16-93ff-4569-9fbb-4f3842c58bec	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	UNICHEM PHARMACEUTICALS (USA), INC.	5b33e96a-8336-46c4-aac7-4a6c0039cc80	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	AvPAK	f53e1a49-6185-6db4-c867-ffd1241a8cb7	2026-01-11	Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	166aa9e4-3402-4ebd-baa5-07a8da8aae56	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	1a2a5e08-2697-4a00-94fe-de07148acbd9	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	bc304b04-9373-4e47-905d-6b3367ad3be7	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	d34fae51-3658-4456-b3ea-1217f0f52260	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	cf143926-439b-4005-be0e-1e049b44c044	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	f0416c8c-faae-4e31-aa50-1fb7df10abf0	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	9929c166-8ba3-4159-a5f9-4618d5d227b0	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Golden State Medical Supply, Inc.	74355cd2-b50e-0dc2-e053-2a91aa0aa164	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	8dc86db1-2a09-4625-80eb-ff6ce9de2d7a	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flecainide Acetate
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

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