ANDA 206550

HIKMA

FDA Drug Application

Application #206550

Application Sponsors

ANDA 206550

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	250MG	0	FLUCYTOSINE	FLUCYTOSINE
002	CAPSULE;ORAL	500MG	0	FLUCYTOSINE	FLUCYTOSINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206550
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCYTOSINE","activeIngredients":"FLUCYTOSINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCYTOSINE","activeIngredients":"FLUCYTOSINE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-17
        )

)