Home Applications 207500 Application 207500
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CRESEMBA ISAVUCONAZONIUM SULFATE CAPSULE;ORAL 186MG Yes Yes 002 CRESEMBA ISAVUCONAZONIUM SULFATE CAPSULE;ORAL 74.5MG Yes No
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 N207500-001 CRESEMBA ISAVUCONAZONIUM SULFATE 186MG CAPSULE / ORAL RLD, RS 2015-03-06 N207500-002 CRESEMBA ISAVUCONAZONIUM SULFATE 74.5MG CAPSULE / ORAL RLD 2022-11-22
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207500-001 6812238 2025-10-31 Drug substance 2015-04-01 N207500-001 6812238*PED 2026-04-30 Pediatric extension N207500-001 10206879 2027-09-14 Drug product 2021-12-03 N207500-001 10603280 2027-09-14 Drug product 2021-12-03 N207500-001 10206879*PED 2028-03-14 Pediatric extension N207500-001 10603280*PED 2028-03-14 Pediatric extension N207500-002 6812238 2025-10-31 Drug substance 2023-06-29 N207500-002 6812238*PED 2026-04-30 Pediatric extension N207500-002 10206879 2027-09-14 Drug product 2022-12-21 N207500-002 10603280 2027-09-14 Drug product 2022-12-21 N207500-002 10206879*PED 2028-03-14 Pediatric extension N207500-002 10603280*PED 2028-03-14 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 21 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 · 65 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 2026-02-19 14:30 UTC 2026-02 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207500-002 CRESEMBA 74.5MG CAPSULE / ORAL RLD 2022-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207500-001 CRESEMBA 186MG CAPSULE / ORAL RLD, RS 2015-03-06 b00525d2431f…
Observed Orange Book patent history# Patent history page 1 of 8 · 293 observed states.
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 N207500-001 6812238 2025-10-31 Drug substance 2015-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-001 6812238*PED 2026-04-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-001 10206879 2027-09-14 Drug product 2021-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-001 10603280 2027-09-14 Drug product 2021-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-001 10206879*PED 2028-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-001 10603280*PED 2028-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 6812238 2025-10-31 Drug substance 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 6812238*PED 2026-04-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 10206879 2027-09-14 Drug product 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 10603280 2027-09-14 Drug product 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 10206879*PED 2028-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207500-002 10603280*PED 2028-03-14 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 6812238 2025-10-31 Drug substance 2015-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 6812238*PED 2026-04-30 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 10206879 2027-09-14 Drug product 2021-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 10603280 2027-09-14 Drug product 2021-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 10206879*PED 2028-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-001 10603280*PED 2028-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 6812238 2025-10-31 Drug substance 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 6812238*PED 2026-04-30 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 10206879 2027-09-14 Drug product 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 10603280 2027-09-14 Drug product 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 10206879*PED 2028-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207500-002 10603280*PED 2028-03-14 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207500-001 6812238 2025-10-31 Drug substance 2015-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-001 6812238*PED 2026-04-30 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-001 10206879 2027-09-14 Drug product 2021-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-001 10603280 2027-09-14 Drug product 2021-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-001 10206879*PED 2028-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-001 10603280*PED 2028-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 6812238 2025-10-31 Drug substance 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 6812238*PED 2026-04-30 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 10206879 2027-09-14 Drug product 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 10603280 2027-09-14 Drug product 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 10206879*PED 2028-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207500-002 10603280*PED 2028-03-14 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207500-001 6812238 2025-10-31 Drug substance 2015-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207500-001 6812238*PED 2026-04-30 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207500-001 10206879 2027-09-14 Drug product 2021-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207500-001 10603280 2027-09-14 Drug product 2021-12-03 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 16 · 602 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-0520 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-2860 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current 0469-2860 CRESEMBA isavuconazonium sulfate Astellas Pharma US, Inc. NDA Current