NDA 205383

INTERPHARMA PRAHA AS

FDA Drug Application

Application #205383

Documents

• Letter: 2015-04-03
• Label: 2015-04-28
• Review: 2015-04-22
• Summary Review: 2015-04-22
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 205383

INTERPHARMA PRAHA AS

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

9.7GM/BOT

0

ORALTAG

IOHEXOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2015-03-26

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

INTERPHARMA PRAHA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205383
            [companyName] => INTERPHARMA PRAHA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORALTAG","activeIngredients":"IOHEXOL","strength":"9.7GM\/BOT","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/26\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205383Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/26\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205383Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205383Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205383Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205383Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-03-26
        )

)