BLA 020168

GENENTECH

FDA Drug Application

Application #020168

Documents

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

Application Sponsors

BLA 020168

GENENTECH

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	5MG/VIAL	0	NUTROPIN	SOMATROPIN
002	INJECTABLE;INJECTION	10MG/VIAL	0	NUTROPIN	SOMATROPIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1993-11-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-08-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	1995-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-02-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	1995-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-11-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2000-08-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-09-17	STANDARD
LABELING; Labeling	SUPPL	24	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	5	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	13	Null	14
SUPPL	14	Null	14
SUPPL	15	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	24	Null	15

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20168
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUTROPIN","activeIngredients":"SOMATROPIN","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NUTROPIN","activeIngredients":"SOMATROPIN","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NUTROPIN","submission":"SOMATROPIN","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NUTROPIN","submission":"SOMATROPIN","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)