NDA 050519

LILLY

FDA Drug Application

Application #050519

Documents

• Letter: 2003-04-18

Application Sponsors

NDA 050519

LILLY

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1.2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

NEBCIN

TOBRAMYCIN SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1979-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-05-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-11-04
LABELING; Labeling	SUPPL	6	AP	1991-10-28
LABELING; Labeling	SUPPL	8	AP	1992-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1980-09-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	1981-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1981-06-05	STANDARD
LABELING; Labeling	SUPPL	12	AP	1981-03-06
LABELING; Labeling	SUPPL	13	AP	1981-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-08-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	1981-10-02
LABELING; Labeling	SUPPL	16	AP	1982-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1982-07-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	1993-04-01
LABELING; Labeling	SUPPL	19	AP	1997-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-01-02	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	1997-10-01	STANDARD
LABELING; Labeling	SUPPL	23	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-04-02	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50519
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)