NDA 205787

KALEO INC

FDA Drug Application

Application #205787

Documents

• Label: 2014-04-03
• Review: 2014-12-18
• Summary Review: 2014-04-03
• Letter: 2014-04-03

Application Sponsors

NDA 205787

KALEO INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

0.4MG/0.4ML (0.4MG/0.4ML)

1

EVZIO

NALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination	ORIG	1	AP	2014-04-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-05-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2016-06-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-06-23	PRIORITY

Submissions Property Types

ORIG	1	Null	2
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0

CDER Filings

KALEO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205787
            [companyName] => KALEO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVZIO","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.4MG\/0.4ML (0.4MG\/0.4ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/03\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205787Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205787Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205787Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205787Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205787Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/23\/2016","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/06\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/11\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-06-23
        )

)