NDA 050010

LILLY

FDA Drug Application

Application #050010

Application Sponsors

NDA 050010

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SUSPENSION;ORAL	EQ 125MG BASE/5ML	0	ILOSONE	ERYTHROMYCIN ESTOLATE
002	SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	ILOSONE	ERYTHROMYCIN ESTOLATE

FDA Submissions

	ORIG	1	AP	1967-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-04-10
LABELING; Labeling	SUPPL	6	AP	1990-12-10
LABELING; Labeling	SUPPL	7	AP	1990-12-10
LABELING; Labeling	SUPPL	8	AP	1991-01-07
LABELING; Labeling	SUPPL	9	AP	1990-04-16
LABELING; Labeling	SUPPL	12	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1991-08-22
LABELING; Labeling	SUPPL	16	AP	1992-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-04-18
LABELING; Labeling	SUPPL	19	AP	1993-10-28
LABELING; Labeling	SUPPL	22	AP	1997-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-10-16

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50010
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)