NDA 212125

TEVA PHARMS USA

FDA Drug Application

Application #212125

Documents

• Letter: 2020-12-01
• Label: 2021-08-02
• Review: 2022-05-12

Application Sponsors

NDA 212125

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 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

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2020-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212125
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212125Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)