NDA 212156

PAR STERILE PRODUCTS

FDA Drug Application

Application #212156

Documents

• Letter: 2021-06-17
• Label: 2021-12-03
• Review: 2021-12-20

Application Sponsors

NDA 212156

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INTRAVENOUS	50MG	0	MICAFUNGIN	MICAFUNGIN SODIUM
002	INJECTABLE;INTRAVENOUS	100MG	0	MICAFUNGIN	MICAFUNGIN SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-06-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212156
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN","activeIngredients":"MICAFUNGIN SODIUM","strength":"50MG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MICAFUNGIN","activeIngredients":"MICAFUNGIN SODIUM","strength":"100MG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212156Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-16
        )

)