BLA 019640

LILLY

FDA Drug Application

Application #019640

Documents

• 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
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Letter: 2021-03-01

Application Sponsors

BLA 019640

LILLY

Marketing Status

• Discontinued: 001
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	INJECTABLE;INJECTION	2MG/VIAL	0	HUMATROPE	SOMATROPIN
004	INJECTABLE;INJECTION	5MG/VIAL	0	HUMATROPE	SOMATROPIN
005	INJECTABLE;INJECTION	6MG/VIAL	0	HUMATROPE	SOMATROPIN
006	INJECTABLE;INJECTION	12MG/VIAL	0	HUMATROPE	SOMATROPIN
007	INJECTABLE;INJECTION	24MG/VIAL	0	HUMATROPE	SOMATROPIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1986-10-16	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	1989-05-10
LABELING; Labeling	SUPPL	3	AP	1989-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-04-23	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1990-10-11
LABELING; Labeling	SUPPL	6	AP	1992-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-12-14	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1993-11-18	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1994-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-01-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-09-13	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1995-09-22	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	1996-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-12-15	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1996-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-11-22	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1996-08-05	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	1997-03-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	1997-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-06-13	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1997-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1999-02-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1999-09-07	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2002-06-10	STANDARD
LABELING; Labeling	SUPPL	26	AP	2001-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2001-01-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-05-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2001-05-22	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2002-12-04	STANDARD
LABELING; Labeling	SUPPL	32	AP	2003-03-24	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2003-07-25	STANDARD
LABELING; Labeling	SUPPL	40	AP	2004-09-22	STANDARD
EFFICACY; Efficacy	SUPPL	45	AP	2005-10-12	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2006-06-28	N/A
LABELING; Labeling	SUPPL	47	AP	2006-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2006-10-26	N/A
EFFICACY; Efficacy	SUPPL	58	AP	2006-11-01	UNKNOWN
EFFICACY; Efficacy	SUPPL	68	AP	2009-03-12	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2009-01-12	N/A
LABELING; Labeling	SUPPL	78	AP	2010-07-28	UNKNOWN
LABELING; Labeling	SUPPL	84	AP	2011-02-23	UNKNOWN
LABELING; Labeling	SUPPL	86	AP	2011-08-22	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	2013-05-24	PRIORITY
LABELING; Labeling	SUPPL	91	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	92	AP	2014-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	2014-01-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	2014-04-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	2014-08-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	97	AP	2014-09-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	2014-11-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	103	AP	2016-12-20	STANDARD
LABELING; Labeling	SUPPL	104	AP	2016-12-13	STANDARD
LABELING; Labeling	SUPPL	105	AP	2019-10-28	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	4	Null	14
SUPPL	7	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	14	Null	14
SUPPL	16	Null	14
SUPPL	20	Null	14
SUPPL	22	Null	14
SUPPL	24	Null	14
SUPPL	28	Null	14
SUPPL	29	Null	14
SUPPL	30	Null	14
SUPPL	68	Null	6
SUPPL	78	Null	6
SUPPL	84	Null	7
SUPPL	86	Null	15
SUPPL	90	Null	14
SUPPL	91	Null	7
SUPPL	92	Null	7
SUPPL	93	Null	14
SUPPL	95	Null	14
SUPPL	96	Null	14
SUPPL	97	Null	14
SUPPL	98	Null	14
SUPPL	104	Null	7
SUPPL	105	Null	15

TE Codes

004	Prescription
005	Prescription

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19640
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)