NDA 019863

EMD SERONO

FDA Drug Application

Application #019863

Documents

• Review: 2008-02-19
• Review: 2008-02-19

Application Sponsors

NDA 019863

EMD SERONO

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

GEREF

SERMORELIN ACETATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-04-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	1998-03-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2001-10-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19863
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)