FDA.reportPublic FDA data

Application 212410

Type
ANDA
Sponsor
RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOFETILIDEDOFETILIDECAPSULE;ORAL0.125MGNoNo
002DOFETILIDEDOFETILIDECAPSULE;ORAL0.25MGNoNo
003DOFETILIDEDOFETILIDECAPSULE;ORAL0.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212410-001DOFETILIDEDOFETILIDE0.125MGCAPSULE / ORAL2019-12-27
A212410-002DOFETILIDEDOFETILIDE0.25MGCAPSULE / ORAL2019-12-27
A212410-003DOFETILIDEDOFETILIDE0.5MGCAPSULE / ORAL2019-12-27

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 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212410-002DOFETILIDE0.25MGCAPSULE / ORAL2019-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212410-003DOFETILIDE0.5MGCAPSULE / ORAL2019-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212410-001DOFETILIDE0.125MGCAPSULE / ORAL2019-12-271e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-03-12 10:30 UTC2021-03A212410-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212410-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212410-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212410-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212410-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212410-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212410-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212410-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212410-003AB1c0c555d07b60…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DofetilideDOFETILIDEDr. Reddy's Labratories Inc.28fe0cac-62fd-997d-8065-561aaf1541c42026-08-13Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DofetilideDOFETILIDEMajor Pharmaceuticals26de5f8c-8cec-46f6-a468-69451758a2782026-05-13Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DofetilideDOFETILIDEREMEDYREPACK INC.a5d943c6-1960-4318-9e6f-6bf69ac499532026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
TikosynDOFETILIDEPfizer Laboratories Div Pfizer Inc02438044-d6a3-49e9-a1ac-3aad21ef2c8c2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOFETILIDE
DofetilideDOFETILIDEAccord Healthcare, Inc.4c1a5a6d-bd69-473c-8caa-d0d242b7708d2025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DofetilideDOFETILIDEEXELAN PHARMACEUTICALS, INC.41ccbb23-ae03-44bd-b438-0b0a8388d56b2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DofetilideDOFETILIDEAurobindo Pharma Limited85f2b35c-31d5-4161-b342-c781d23945a52024-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DOFETILIDEDOFETILIDENorthStar RxLLC4552d82a-dd28-410c-9642-1af060832b472023-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOFETILIDE
generic name: DOFETILIDE
DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.e6caaf44-4a3e-46ef-85fa-f97f682fbdd62023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOFETILIDE
generic name: DOFETILIDE
DofetilideDOFETILIDEBionpharma Inc.0e60aa4b-72c2-4ef4-ab01-c9cf94240ff12023-03-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DofetilideDOFETILIDESigmapharm Laboratories, LLC0cb2ef7d-e35b-483b-9985-cfef99d7b96f2023-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE
DofetilideDOFETILIDENovadoz Pharmaceuticals LLCb8323987-90fe-4e6c-a71c-76e3c501713c2022-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dofetilide
generic name: DOFETILIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-230DOFETILIDEdofetilideIngenus Pharmaceuticals, LLCANDACurrent
50742-230DOFETILIDEdofetilideIngenus Pharmaceuticals, LLCANDACurrent
50742-231DOFETILIDEdofetilideIngenus Pharmaceuticals, LLCANDACurrent
50742-231DOFETILIDEdofetilideIngenus Pharmaceuticals, LLCANDACurrent
50742-232DOFETILIDEdofetilideIngenus Pharmaceuticals, LLCANDACurrent
50742-232DOFETILIDEdofetilideIngenus Pharmaceuticals, LLCANDACurrent