Application Sponsors
ANDA 215381 | NANJING KING-FRIEND | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 50MG BASE/VIAL | 0 | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM |
002 | INJECTABLE;INTRAVENOUS | EQ 100MG BASE/VIAL | 0 | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-09-28 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
NANJING KING-FRIEND
cder:Array
(
[0] => Array
(
[ApplNo] => 215381
[companyName] => NANJING KING-FRIEND
[docInserts] => ["",""]
[products] => [{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-09-28
)
)