ANDA 213665

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213665

Application Sponsors

ANDA 213665

AUROBINDO PHARMA LTD

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	2020-05-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213665
            [companyName] => AUROBINDO PHARMA LTD
            [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":"05\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-01
        )

)