BLA 210089

CIS BIO INTL

FDA Drug Application

Application #210089

Documents

• Label: 2020-03-23
• Other: 2020-03-24
• Letter: 2020-03-24
• Review: 2020-10-13

Application Sponsors

BLA 210089

CIS BIO INTL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG

2

PULMOTECH MAA

TECHNETIUM TC99M ALBUMIN AGGREGATED

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-03-20

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

CIS BIO INTL

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            [companyName] => CIS BIO INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PULMOTECH MAA","activeIngredients":"TECHNETIUM TC99M ALBUMIN AGGREGATED","strength":"2MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/20\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210089s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210089s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210089Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-20
        )

)