Home Applications 217417 Application 217417
Type NDA
Sponsor MUNDIPHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REZZAYO REZAFUNGIN ACETATE POWDER;INTRAVENOUS EQ 200MG 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 N217417-001 REZZAYO REZAFUNGIN ACETATE EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20
Orange Book exclusivity# Current exclusivity 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.
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 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 167 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 100 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 REZZAYO REZAFUNGIN Melinta Therapeutics, LLC 90073508-6dca-4d27-aa5a-ed837737c35b 2026-07-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 217417 application number: NDA217417
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 84443 SUPPL 2025-12-18 84387 SUPPL 2025-12-11 74014 ORIG 2023-04-18 73833 ORIG 2023-03-23 73827 ORIG 2023-03-23