NDA 205579

EAGLE PHARMS

FDA Drug Application

Application #205579

Documents

• Letter: 2014-07-24
• Label: 2014-07-24
• Review: 2016-03-23
• Summary Review: 2016-03-23
• Letter: 2020-08-26
• Label: 2020-09-01

Application Sponsors

NDA 205579

EAGLE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;INTRAVENOUS

250MG/VIAL

1

RYANODEX

DANTROLENE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2014-07-22	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2020-08-25	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	7	Null	7

CDER Filings

EAGLE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205579
            [companyName] => EAGLE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYANODEX","activeIngredients":"DANTROLENE SODIUM","strength":"250MG\/VIAL","dosageForm":"FOR SUSPENSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/25\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205579s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205579s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205579s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205579Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205579Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205579Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/25\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205579s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205579Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"10\/01\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-25
        )

)