Home Applications 207501 Application 207501
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CRESEMBA ISAVUCONAZONIUM SULFATE POWDER;INTRAVENOUS 372MG 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 N207501-001 CRESEMBA ISAVUCONAZONIUM SULFATE 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06
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 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 N207501-001 6812238*PED 2026-04-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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 2 · 44 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 2026-10-15 13:18:30 2026-09 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 2 of 2 · 71 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2021-12-28 21:50 UTC 2021-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207501-001 6812238 2020-10-31 Drug substance 2015-04-01 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207501-001 6812238 2020-10-31 Drug substance 2015-04-01 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207501-001 6812238 2020-10-31 Drug substance 2015-04-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207501-001 6812238 2020-10-31 Drug substance 2015-04-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207501-001 6812238*PED 2026-05-01 Pediatric extension 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N207501-001 6812238*PED 2026-05-01 Pediatric extension 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N207501-001 6812238*PED 2026-05-01 Pediatric extension ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N207501-001 6812238*PED 2026-04-30 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 11 · 417 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0420 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current