BLA 020604

EMD SERONO

FDA Drug Application

Application #020604

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
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• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
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• Other: 2020-03-23
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• Other: 2020-03-23
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• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-22
• Label: 2021-03-05

Application Sponsors

BLA 020604

EMD SERONO

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	INJECTABLE;INJECTION	6MG/VIAL	0	SEROSTIM	SOMATROPIN
002	INJECTABLE;INJECTION	5MG/VIAL	0	SEROSTIM	SOMATROPIN
003	INJECTABLE;INJECTION	4MG/VIAL	0	SEROSTIM	SOMATROPIN
004	INJECTABLE;INJECTION	8.8MG/VIAL	0	SEROSTIM	SOMATROPIN
005	INJECTABLE;SUBCUTANEOUS	6MG/0.5ML (6MG/0.5ML)	0	SEROSTIM LQ	SOMATROPIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1996-08-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-07-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-01-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-07-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-07-09	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2000-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-09-18	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2000-07-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2000-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-04-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-07-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-08-17	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2001-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-05-03	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2001-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-07-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-09-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-11-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-12-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-12-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-12-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-10-17	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2003-12-01	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2003-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2005-02-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2004-07-09	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2005-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2006-09-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2006-11-27	N/A
EFFICACY; Efficacy	SUPPL	40	AP	2007-07-13	STANDARD
LABELING; Labeling	SUPPL	44	AP	2007-08-30	STANDARD
LABELING; Labeling	SUPPL	48	AP	2009-08-31	STANDARD
LABELING; Labeling	SUPPL	49	AP	2012-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	2012-11-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2013-02-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	2013-01-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	2013-02-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2013-02-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	2013-04-05	PRIORITY
LABELING; Labeling	SUPPL	74	AP	2017-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	2013-12-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	2013-12-12	PRIORITY
LABELING; Labeling	SUPPL	78	AP	2014-06-18	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	2014-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	2014-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	82	AP	2014-08-11	PRIORITY
LABELING; Labeling	SUPPL	89	AP	2016-12-13	STANDARD
LABELING; Labeling	SUPPL	90	AP	2016-12-13	STANDARD
LABELING; Labeling	SUPPL	93	AP	2017-05-09	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	13	Null	14
SUPPL	15	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	20	Null	14
SUPPL	21	Null	14
SUPPL	22	Null	14
SUPPL	23	Null	14
SUPPL	29	Null	14
SUPPL	30	Null	14
SUPPL	34	Null	14
SUPPL	48	Null	6
SUPPL	49	Null	6
SUPPL	58	Null	14
SUPPL	65	Null	14
SUPPL	67	Null	14
SUPPL	68	Null	14
SUPPL	71	Null	14
SUPPL	73	Null	14
SUPPL	74	Null	7
SUPPL	75	Null	14
SUPPL	76	Null	14
SUPPL	78	Null	6
SUPPL	80	Null	14
SUPPL	81	Null	14
SUPPL	82	Null	14
SUPPL	89	Null	7
SUPPL	90	Null	7
SUPPL	93	Null	6

TE Codes

001	Prescription
002	Prescription

CDER Filings

EMD SERONO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20604
            [companyName] => EMD SERONO
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEROSTIM","activeIngredients":"SOMATROPIN","strength":"6MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEROSTIM","activeIngredients":"SOMATROPIN","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEROSTIM","activeIngredients":"SOMATROPIN","strength":"4MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEROSTIM","activeIngredients":"SOMATROPIN","strength":"8.8MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SEROSTIM LQ","activeIngredients":"SOMATROPIN","strength":"6MG\/0.5ML (6MG\/0.5ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SEROSTIM","submission":"SOMATROPIN","actionType":"6MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SEROSTIM","submission":"SOMATROPIN","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SEROSTIM","submission":"SOMATROPIN","actionType":"4MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SEROSTIM","submission":"SOMATROPIN","actionType":"8.8MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SEROSTIM LQ","submission":"SOMATROPIN","actionType":"6MG\/0.5ML (6MG\/0.5ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)