Application 210466

Type
ANDA
Sponsor
SUN PHARM

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 1.

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
A210466-001DOFETILIDEDOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09
A210466-002DOFETILIDEDOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09
A210466-003DOFETILIDEDOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210466-001AB
A210466-002AB
A210466-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210466-002DOFETILIDE0.25MGCAPSULE / ORALAB2018-10-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210466-003DOFETILIDE0.5MGCAPSULE / ORALAB2018-10-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210466-001DOFETILIDE0.125MGCAPSULE / ORALAB2018-10-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210466-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210466-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210466-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210466-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210466-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210466-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210466-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210466-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210466-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210466-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210466-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210466-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210466-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210466-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210466-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210466-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210466-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210466-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210466-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210466-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210466-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210466-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210466-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210466-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210466-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210466-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210466-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210466-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210466-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210466-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210466-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210466-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210466-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210466-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210466-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210466-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210466-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210466-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210466-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210466-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOFETILIDEDOFETILIDENorthStar RxLLC4552d82a-dd28-410c-9642-1af060832b472023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210466
application number: ANDA210466
DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.e6caaf44-4a3e-46ef-85fa-f97f682fbdd62023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210466
application number: ANDA210466
ndc (product): 47335-063
ndc (product): 47335-062
ndc (product): 47335-061

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-061DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-061DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-061DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-062DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-062DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-062DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-063DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-063DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-063DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent