ANDA 203851

MYLAN LABS LTD

FDA Drug Application

Application #203851

Documents

• Letter: 2017-12-01

Application Sponsors

ANDA 203851

MYLAN LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	1,000 UNITS/ML	0	HEPARIN SODIUM	HEPARIN SODIUM
002	INJECTABLE;INJECTION	5,000 UNITS/ML	0	HEPARIN SODIUM	HEPARIN SODIUM
003	INJECTABLE;INJECTION	10,000 UNITS/ML	0	HEPARIN SODIUM	HEPARIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-30
LABELING; Labeling	SUPPL	10	AP	2020-07-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	10	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203851
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"10,000 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\\\/203851Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/29\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-29
        )

)