BLA 761106

GENENTECH INC

FDA Drug Application

Application #761106

Documents

• Label: 2019-02-28
• Letter: 2019-03-01
• Review: 2019-10-17

Application Sponsors

BLA 761106

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

600MG;10000UNITS

0

HERCEPTIN HYLECTA

TRASTUZUMAB; HYALURONIDASE-OYSK

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761106
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HERCEPTIN HYLECTA","activeIngredients":"TRASTUZUMAB; HYALURONIDASE-OYSK","strength":"600MG;10000UNITS","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/28\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761106Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761106Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761106Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761106Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-02-28
        )

)