isavuconazonium Oral Capsule
- Brand(s)
- Cresemba
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Fujisawa Healthcare, Inc. (2015-06-30)
- Oldest Current Product
- 2015-11-04
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\ISAVUCONAZONIUM
- FDAOB
- ORAL\CAPSULE\ISAVUCONAZONIUM SULFATE
- SPL Active
- ORAL\CAPSULE\ISAVUCONAZONIUM SULFATE
- SPL Moiety
- ORAL\CAPSULE\ISAVUCONAZOLE
product(s) by strength(s)
isavuconazonium sulfate 186 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 004690520 | Cresemba | NDA | Fujisawa Healthcare, Inc. | 2015-11-04 | ISAVUCONAZONIUM SULFATE | ORAL | CAPSULE | NDA207500 | 8f7f73b8-586a-4df0-935f-fecd4696c16c |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA207500 | CRESEMBA | ASTELLAS PHARMA US INC | 2015-03-06 | p6812238 p7459561 | NEW CHEMICAL ENTITY [2020-03-06] Generating Antibiotic Incentives Now [2027-03-06] Generating Antibiotic Incentives Now [2025-03-06] ORPHAN DRUG EXCLUSIVITY [2022-03-06] | NDA207500_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA207500_001 | RX | ISAVUCONAZONIUM SULFATE (186MG) | ORAL | CAPSULE | True | 2015-03-06 | CRESEMBA |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6812238 (view patent) | 2020-10-31 | NDA207500, NDA207501 | isavuconazonium Injection |
| 2 | p7459561 (view patent) | 2020-10-31 | NDA207500, NDA207501 | isavuconazonium Injection |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 8f7f73b8-586a-4df0-935f-fecd4696c16c (view SPL) | These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full prescribing information for CRESEMBA. CRESEMBA (isavuconazonium sulfate) Capsules for oral administrationFor Injection for intravenous administrationInitial U.S. Approval: 2015 | prescription | Human Prescription | Fujisawa Healthcare, Inc. | 2015-06-30 | 5 | 004690520, 004690420 | isavuconazonium Injection |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII