Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE; INJECTION | 50MG | 0 | MYCAMINE | MICAFUNGIN SODIUM |
| 002 | INJECTABLE;INTRAVENOUS | EQ 50MG BASE/VIAL | 1 | MYCAMINE | MICAFUNGIN SODIUM |
| 003 | INJECTABLE;INTRAVENOUS | EQ 100MG BASE/VIAL | 1 | MYCAMINE | MICAFUNGIN SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-03-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2006-06-27 | N/A |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2008-01-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2007-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2011-06-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2013-04-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2013-06-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2015-08-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2016-06-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 2016-08-26 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2019-12-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | TA | 2020-07-31 | N/A |
Submissions Property Types
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 23 | Null | 15 |
TE Codes
| 002 | Prescription | AP |
| 003 | Prescription | AP |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 21506
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"MYCAMINE","activeIngredients":"MICAFUNGIN SODIUM","strength":"50MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MYCAMINE","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MYCAMINE","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/20\/2019","submission":"SUPPL-23","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021506s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021506s019lbl.pdf\"}]","notes":"Please see"},{"actionDate":"08\/26\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021506s019lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/21\/2013","submission":"SUPPL-15","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021506s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021506s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021506s011s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021506s011s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2008","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021506s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2007","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021506s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2006","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021506s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2006","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021506s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21506,21754lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MYCAMINE","submission":"MICAFUNGIN SODIUM","actionType":"50MG","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MYCAMINE","submission":"MICAFUNGIN SODIUM","actionType":"EQ 50MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MYCAMINE","submission":"MICAFUNGIN SODIUM","actionType":"EQ 100MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-12-20
)
)