ANDA 203852

MYLAN LABS LTD

FDA Drug Application

Application #203852

Documents

• Letter: 2017-12-01

Application Sponsors

ANDA 203852

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20,000 UNITS/ML

0

HEPARIN SODIUM

HEPARIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-30
LABELING; Labeling	SUPPL	6	AP	2021-03-30	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	6	Null	7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203852
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"20,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203852Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-30
        )

)