NDA 050482

LILLY

FDA Drug Application

Application #050482

Application Sponsors

NDA 050482

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 007

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	KEFLIN	CEPHALOTHIN SODIUM
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	KEFLIN	CEPHALOTHIN SODIUM
003	INJECTABLE;INJECTION	EQ 4GM BASE/VIAL	0	KEFLIN	CEPHALOTHIN SODIUM
007	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	0	KEFLIN	CEPHALOTHIN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1974-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-02-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	1983-03-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	1983-03-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	1983-06-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	1983-06-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	1983-08-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	1983-08-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	1983-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-10-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	1983-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-06-07	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	1985-11-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	1985-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1986-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1987-03-20	STANDARD
LABELING; Labeling	SUPPL	27	AP	1993-01-19	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50482
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)