Application 208519

Type: ANDA
Sponsor: PAR PHARM INC

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 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	Approval date
A208519-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	2018-10-09
A208519-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	2018-10-09
A208519-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	2018-10-09

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	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL		2018-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL		2018-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL		2018-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208519-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2018-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208519-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2018-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208519-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2018-10-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208519-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208519-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208519-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208519-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208519-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208519-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208519-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208519-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208519-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208519-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208519-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208519-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208519-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208519-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208519-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208519-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208519-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208519-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208519-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208519-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208519-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208519-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208519-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208519-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208519-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208519-001	AB	1	`5c6f7cd8ea54…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dofetilide	DOFETILIDE	Major Pharmaceuticals	26de5f8c-8cec-46f6-a468-69451758a278	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Dofetilide	DOFETILIDE	REMEDYREPACK INC.	a5d943c6-1960-4318-9e6f-6bf69ac49953	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Tikosyn	DOFETILIDE	Pfizer Laboratories Div Pfizer Inc	02438044-d6a3-49e9-a1ac-3aad21ef2c8c	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DOFETILIDE
Dofetilide	DOFETILIDE	Accord Healthcare, Inc.	4c1a5a6d-bd69-473c-8caa-d0d242b7708d	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Dofetilide	DOFETILIDE	EXELAN PHARMACEUTICALS, INC.	41ccbb23-ae03-44bd-b438-0b0a8388d56b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Dofetilide	DOFETILIDE	Dr. Reddy's Labratories Inc.	28fe0cac-62fd-997d-8065-561aaf1541c4	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Dofetilide	DOFETILIDE	Aurobindo Pharma Limited	85f2b35c-31d5-4161-b342-c781d23945a5	2024-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
DOFETILIDE	DOFETILIDE	NorthStar RxLLC	4552d82a-dd28-410c-9642-1af060832b47	2023-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOFETILIDE generic name: DOFETILIDE
DOFETILIDE	DOFETILIDE	Sun Pharmaceutical Industries, Inc.	e6caaf44-4a3e-46ef-85fa-f97f682fbdd6	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOFETILIDE generic name: DOFETILIDE
Dofetilide	DOFETILIDE	Bionpharma Inc.	0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1	2023-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Dofetilide	DOFETILIDE	Sigmapharm Laboratories, LLC	0cb2ef7d-e35b-483b-9985-cfef99d7b96f	2023-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE
Dofetilide	DOFETILIDE	Novadoz Pharmaceuticals LLC	b8323987-90fe-4e6c-a71c-76e3c501713c	2022-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dofetilide generic name: DOFETILIDE