Application 212750

Type: ANDA
Sponsor: GRANULES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOFETILIDE	DOFETILIDE	CAPSULE;ORAL	0.125MG	No	No
002	DOFETILIDE	DOFETILIDE	CAPSULE;ORAL	0.25MG	No	No
003	DOFETILIDE	DOFETILIDE	CAPSULE;ORAL	0.5MG	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
A212750-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14
A212750-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14
A212750-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212750-001	AB
A212750-002	AB
A212750-003	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 · 105 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	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212750-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212750-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212750-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2021-10-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212750-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212750-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212750-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212750-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212750-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212750-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212750-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212750-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212750-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212750-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212750-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212750-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212750-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212750-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212750-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212750-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212750-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212750-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212750-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212750-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212750-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212750-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212750-003	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212750-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212750-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212750-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212750-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212750-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212750-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212750-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212750-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212750-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212750-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212750-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212750-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212750-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212750-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212750-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212750-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212750-002	AB	1	`a67488948f0b…`

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
Dofetilide	DOFETILIDE	EXELAN PHARMACEUTICALS, INC.	41ccbb23-ae03-44bd-b438-0b0a8388d56b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212750 application number: ANDA212750

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
70010-024	Dofetilide 0.125mg	Dofetilide 0.125mg	Granules Pharmaceuticals Inc.	ANDA	Current
70010-025	Dofetilide 0.25mg	Dofetilide 0.25mg	Granules Pharmaceuticals Inc.	ANDA	Current
70010-026	Dofetilide 0.5mg	Dofetilide 0.5mg	Granules Pharmaceuticals Inc.	ANDA	Current