Home Applications 020931 Application 020931
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIKOSYN DOFETILIDE CAPSULE;ORAL 0.125MG Yes No 002 TIKOSYN DOFETILIDE CAPSULE;ORAL 0.25MG Yes No 003 TIKOSYN DOFETILIDE CAPSULE;ORAL 0.5MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020931-001 TIKOSYN DOFETILIDE 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 N020931-002 TIKOSYN DOFETILIDE 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 N020931-003 TIKOSYN DOFETILIDE 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020931-002 TIKOSYN 0.25MG CAPSULE / ORAL AB RLD 1999-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020931-003 TIKOSYN 0.5MG CAPSULE / ORAL AB RLD, RS 1999-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020931-001 TIKOSYN 0.125MG CAPSULE / ORAL AB RLD 1999-10-01 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-5800 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5800 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5800 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5800 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5800 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5810 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5810 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5810 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5810 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5810 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5820 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5820 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5820 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5820 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 0069-5820 Tikosyn dofetilide Pfizer Laboratories Div Pfizer Inc NDA Current 59762-0037 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0037 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0037 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0037 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0037 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0038 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0038 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0038 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0038 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0038 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0039 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0039 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0039 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0039 Dofetilide dofetilide Greenstone LLC NDA Current 59762-0039 Dofetilide dofetilide Greenstone LLC NDA Current 69189-5800 Tikosyn dofetilide Avera McKennan Hospital NDA Current 69189-5810 Tikosyn dofetilide Avera McKennan Hospital NDA Current 69189-5820 Tikosyn dofetilide Avera McKennan Hospital NDA Current