NDA 050477

LILLY

FDA Drug Application

Application #050477

Documents

• Letter: 2003-04-18

Application Sponsors

NDA 050477

LILLY

Marketing Status

• Discontinued: 005

Application Products

005

INJECTABLE;INJECTION

EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

NEBCIN

TOBRAMYCIN SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1975-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-09-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	1985-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-03-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	1987-04-02
LABELING; Labeling	SUPPL	6	AP	1987-07-21
LABELING; Labeling	SUPPL	7	AP	1991-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-10-28	STANDARD
LABELING; Labeling	SUPPL	9	AP	1975-07-30
EFFICACY; Efficacy	SUPPL	10	AP	1975-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-01-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	1976-02-23
LABELING; Labeling	SUPPL	13	AP	1976-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1980-05-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	1992-08-06
LABELING; Labeling	SUPPL	16	AP	1993-04-01
LABELING; Labeling	SUPPL	17	AP	1997-05-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	1997-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-04-03	STANDARD
EFFICACY; Efficacy	SUPPL	21	AP	1997-10-01	STANDARD
LABELING; Labeling	SUPPL	22	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-03-04	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-04-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50477
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)