Home Applications 214759 Application 214759
Type NDA
Sponsor MEDEXUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRAFAPEX TREOSULFAN POWDER;INTRAVENOUS 1GM/VIAL Yes Yes 002 GRAFAPEX TREOSULFAN POWDER;INTRAVENOUS 5GM/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214759-001 GRAFAPEX TREOSULFAN 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 N214759-002 GRAFAPEX TREOSULFAN 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214759-001 7199162 2026-10-12 U-4142 2025-02-20 N214759-002 7199162 2026-10-12 U-4142 2025-02-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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.
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 2026-02-19 14:30 UTC 2026-02 N214759-001 GRAFAPEX 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214759-002 GRAFAPEX 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214759-001 GRAFAPEX 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214759-002 GRAFAPEX 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214759-001 GRAFAPEX 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214759-002 GRAFAPEX 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214759-001 GRAFAPEX 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214759-002 GRAFAPEX 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214759-001 GRAFAPEX 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214759-002 GRAFAPEX 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214759-001 GRAFAPEX 1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214759-002 GRAFAPEX 5GM/VIAL POWDER / INTRAVENOUS RLD, RS 2025-01-21 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 2026-02-19 14:30 UTC 2026-02 N214759-001 7199162 2026-03-21 U-4142 2025-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214759-002 7199162 2026-03-21 U-4142 2025-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214759-001 7199162 2026-03-21 U-4142 2025-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214759-002 7199162 2026-03-21 U-4142 2025-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214759-001 7199162 2026-03-21 U-4142 2025-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214759-002 7199162 2026-03-21 U-4142 2025-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214759-001 7199162 2025-10-12 U-4142 2025-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214759-002 7199162 2025-10-12 U-4142 2025-02-20 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214759-001 7199162 2026-10-12 U-4142 2025-02-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214759-002 7199162 2026-10-12 U-4142 2025-02-20 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 GRAFAPEX TREOSULFAN Medexus Pharma, Inc. 2d06b03c-17aa-0492-e063-6294a90abd8f 2025-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214759 application number: NDA214759
Documents# Document, Submission type, Date table Document Submission type Date 81308 ORIG 2025-02-21 81121 SUPPL 2025-02-07 81098 SUPPL 2025-02-06 80915 ORIG 2025-02-04 80904 ORIG 2025-02-04