NDA 212801

RECORDATI RARE

FDA Drug Application

Application #212801

Documents

• Label: 2020-03-09
• Letter: 2020-03-10
• Review: 2020-04-06

Application Sponsors

NDA 212801

RECORDATI RARE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 1MG BASE	1	ISTURISA	OSILODROSTAT PHOSPHATE
002	TABLET;ORAL	EQ 5MG BASE	1	ISTURISA	OSILODROSTAT PHOSPHATE
003	TABLET;ORAL	EQ 10MG BASE	1	ISTURISA	OSILODROSTAT PHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-03-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

RECORDATI RARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212801
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISTURISA","activeIngredients":"OSILODROSTAT PHOSPHATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ISTURISA","activeIngredients":"OSILODROSTAT PHOSPHATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ISTURISA","activeIngredients":"OSILODROSTAT PHOSPHATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212801s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212801s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212801Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/212801Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-06
        )

)