Home Applications 201848 Application 201848
Type NDA
Sponsor DELCATH SYSTEMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HEPZATO MELPHALAN HYDROCHLORIDE POWDER;INTRA-ARTERIAL EQ 50MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N201848-001 HEPZATO MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N201848-001 10098997 2032-11-07 Drug product 2023-09-06 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 N201848-001 9707331 2034-09-17 Drug product 2023-09-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N201848-001 NP 2026-08-14 N201848-001 ODE-438 2030-08-14
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 2026-10-15 13:18:30 2026-09 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 5 of 7 · 250 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 1c564ffb4f44…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hepzato Kit MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION Delcath Systems, Inc. 4f83c8f7-4cc0-4219-88d5-7cfddce91198 2026-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 201848 application number: NDA201848
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 83290 SUPPL 2025-09-05 79809 SUPPL 2024-10-03 79361 SUPPL 2024-08-09 79360 SUPPL 2024-08-09 79324 ORIG 2024-08-07 78547 SUPPL 2024-05-23 78546 SUPPL 2024-05-23 77346 SUPPL 2024-01-29 76358 ORIG 2023-11-06 75071 ORIG 2023-08-15 75067 ORIG 2023-08-15