BLA 761154

MYLAN PHARMS INC

FDA Drug Application

Application #761154

Documents

• Label: 2020-07-07
• Medication Guide: 2020-07-07
• Letter: 2020-07-07
• Review: 2020-10-02
• Letter: 2022-07-15
• Label: 2022-07-15

Application Sponsors

BLA 761154

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG;0.4ML

0

HULIO

ADALIMUMAB-FKJP

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-07-06	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-07-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761154
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761154s000lbl.pdf#page=41"]
            [products] => [{"drugName":"HULIO","activeIngredients":"ADALIMUMAB-FKJP","strength":"20MG;0.4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761154s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761154s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761154Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)