BLA 021597

EMD SERONO

FDA Drug Application

Application #021597

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-22
• Label: 2021-03-09

Application Sponsors

BLA 021597

EMD SERONO

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	4MG/VIAL	0	ZORBTIVE	SOMATROPIN RECOMBINANT
002	INJECTABLE;INJECTION	5MG/VIAL	0	ZORBTIVE	SOMATROPIN RECOMBINANT
003	INJECTABLE;INJECTION	6MG/VIAL	0	ZORBTIVE	SOMATROPIN RECOMBINANT
004	INJECTABLE;INJECTION	8.8MG/VIAL	0	ZORBTIVE	SOMATROPIN RECOMBINANT

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2003-12-01

STANDARD

Submissions Property Types

ORIG

1

Orphan

5

CDER Filings

EMD SERONO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21597
            [companyName] => EMD SERONO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZORBTIVE","activeIngredients":"SOMATROPIN RECOMBINANT","strength":"4MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZORBTIVE","activeIngredients":"SOMATROPIN RECOMBINANT","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZORBTIVE","activeIngredients":"SOMATROPIN RECOMBINANT","strength":"6MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZORBTIVE","activeIngredients":"SOMATROPIN RECOMBINANT","strength":"8.8MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZORBTIVE","submission":"SOMATROPIN RECOMBINANT","actionType":"4MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZORBTIVE","submission":"SOMATROPIN RECOMBINANT","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZORBTIVE","submission":"SOMATROPIN RECOMBINANT","actionType":"6MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZORBTIVE","submission":"SOMATROPIN RECOMBINANT","actionType":"8.8MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)