NDA 206110

FRESENIUS KABI USA

FDA Drug Application

Application #206110

Documents

• Label: 2017-01-03
• Letter: 2017-01-05
• Review: 2017-10-27
• Review: 2017-10-27
• Label: 2018-07-05
• Letter: 2018-07-06
• Label: 2021-04-02
• Letter: 2021-04-05

Application Sponsors

NDA 206110

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	50MG/VIAL	0	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE
002	POWDER;INTRAVENOUS	70MG/VIAL	0	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2016-12-30	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	3	AP	2021-04-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	6

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 206110
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"70MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/28\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206110s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206110s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206110lbl.pdf\"}]","notes":"Please see"}]
            [originalApprovals] => [{"actionDate":"12\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206110lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206110Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/206110Orig1s000TOC.cfm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/206110Orig1s000TOC.cfm\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."}]
            [supplements] => [{"actionDate":"06\/28\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206110s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206110Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-06-28
        )

)