NDA 204820

HIKMA INTL PHARMS

FDA Drug Application

Application #204820

Documents

• Label: 2014-09-30
• Review: 2014-10-10
• Summary Review: 2014-10-10
• Letter: 2014-09-30
• Medication Guide: 2014-10-06

Application Sponsors

NDA 204820

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.6MG

1

MITIGARE

COLCHICINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2014-09-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204820
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM417495.pdf"]
            [products] => [{"drugName":"MITIGARE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/26\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204820s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/26\/2014","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\\\/2014\\\/204820s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204820Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204820Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204820Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2014-09-26
        )

)