FDA.reportPublic FDA data

Application 213220

Type
ANDA
Sponsor
MSN

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
A213220-001DOFETILIDEDOFETILIDE0.125MGCAPSULE / ORALAB2020-01-29
A213220-002DOFETILIDEDOFETILIDE0.25MGCAPSULE / ORALAB2020-01-29
A213220-003DOFETILIDEDOFETILIDE0.5MGCAPSULE / ORALAB2020-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213220-001AB
A213220-002AB
A213220-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213220-001DOFETILIDE0.125MGCAPSULE / ORALAB2020-01-29a50c72e98297…
2026-08-01 22:54:322026-06A213220-002DOFETILIDE0.25MGCAPSULE / ORALAB2020-01-29a50c72e98297…
2026-08-01 22:54:322026-06A213220-003DOFETILIDE0.5MGCAPSULE / ORALAB2020-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213220-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213220-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213220-003AB1a50c72e98297…

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
DofetilideDOFETILIDEREMEDYREPACK INC.a5d943c6-1960-4318-9e6f-6bf69ac499532026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213220
application number: ANDA213220
DofetilideDOFETILIDENovadoz Pharmaceuticals LLCb8323987-90fe-4e6c-a71c-76e3c501713c2022-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213220
application number: ANDA213220
ndc (product): 72205-039
ndc (product): 72205-040
ndc (product): 72205-041

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
69539-130DofetilideDofetilideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-131DofetilideDofetilideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-132DofetilideDofetilideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
72205-039DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-039DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-040DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-040DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-041DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-041DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent