BLA 761201

MYLAN PHARMS INC

FDA Drug Application

Application #761201

Documents

• Label: 2021-07-28
• Letter: 2021-07-29
• Review: 2021-09-02

Application Sponsors

BLA 761201

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	10ML(100UNITS/ML)	0	SEMGLEE	INSULIN GLARGINE-YFGN
002	INJECTABLE;INJECTION	3ML(100UNITS/ML)	0	SEMGLEE	INSULIN GLARGINE-YFGN

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2021-07-28

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761201
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEMGLEE","activeIngredients":"INSULIN GLARGINE-YFGN","strength":"10ML(100UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEMGLEE","activeIngredients":"INSULIN GLARGINE-YFGN","strength":"3ML(100UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761201Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761201Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761201Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-28
        )

)