BLA 019676

GENENTECH

FDA Drug Application

Application #019676

Documents

• 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: 2020-03-23
• 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
• Letter: 2021-03-03

Application Sponsors

BLA 019676

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

Injectable; Injection

N/A

0

NUTROPIN

SOMATROPIN [rDNA origin]

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval	ORIG	1	AP	1994-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-02-01	STANDARD
LABELING; Labeling	SUPPL	5	AP	1995-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-09-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	1995-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-08-07	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1997-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-09-25	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	1999-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-11-03	STANDARD
LABELING; Labeling	SUPPL	15	AP	1999-11-24	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2000-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-09-17	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2005-06-28	UNKNOWN
LABELING; Labeling	SUPPL	21	AP	2005-06-28	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	2006-02-23	UNKNOWN
LABELING; Labeling	SUPPL	30	AP	2007-02-15	STANDARD
LABELING; Labeling	SUPPL	42	AP	2012-04-10	UNKNOWN
LABELING; Labeling	SUPPL	44	AP	2016-12-13	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	6	Null	14
SUPPL	8	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	14	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	42	Null	6
SUPPL	44	Null	6

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19676
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUTROPIN","activeIngredients":"SOMATROPIN [rDNA origin]","strength":"N\/A","dosageForm":"Injectable; Injection","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NUTROPIN","submission":"SOMATROPIN [rDNA origin]","actionType":"N\/A","submissionClassification":"Injectable; Injection","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)