Home Applications 216593 Application 216593
Type NDA
Sponsor NOVA LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XROMI HYDROXYUREA SOLUTION;ORAL 100MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216593-001 XROMI HYDROXYUREA 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216593-001 12409156 2041-12-23 Drug product 2025-09-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216593-001 NP 2027-04-04 N216593-001 ODE-470 2031-04-04
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 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 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 a50c72e98297…
Observed Orange Book exclusivity history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XROMI HYDROXYUREA Nova Laboratories, Ltd. 4b37d336-86da-4363-aef1-34a7d3ba973b 2026-02-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216593 application number: NDA216593
Documents# Document, Submission type, Date table Document Submission type Date 83645 ORIG 2025-10-03 80755 ORIG 2024-12-27 80754 ORIG 2024-12-27 78076 ORIG 2024-12-27 80418 ORIG 2024-11-25 80417 ORIG 2024-11-25 79954 SUPPL 2024-10-21 79953 SUPPL 2024-10-21 79923 SUPPL 2024-10-21 78088 ORIG 2024-04-08 78075 ORIG 2024-04-05