Home Applications 216201 Application 216201
Type ANDA
Sponsor ETON Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NITISINONE NITISINONE CAPSULE;ORAL 2MG No No 002 NITISINONE NITISINONE CAPSULE;ORAL 5MG No No 003 NITISINONE NITISINONE CAPSULE;ORAL 10MG No No 004 NITISINONE NITISINONE CAPSULE;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216201-001 NITISINONE NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 A216201-002 NITISINONE NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 A216201-003 NITISINONE NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 A216201-004 NITISINONE NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 3 · 92 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 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 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.