NDA 203856

HIKMA

FDA Drug Application

Application #203856

Documents

• Letter: 2013-09-19
• Summary Review: 2014-03-06
• Label: 2013-09-18
• Review: 2014-03-06
• Letter: 2019-09-27
• Label: 2019-10-03

Application Sponsors

NDA 203856

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	25MG	1	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE
002	CAPSULE;ORAL	50MG	1	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2013-09-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-09-26	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203856
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/26\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203856s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203856s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/16\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203856s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203856Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203856Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203856Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/26\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203856s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203856Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-26
        )

)