NDA 013378

LILLY

FDA Drug Application

Application #013378

Application Sponsors

NDA 013378

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	500MG	0	DYMELOR	ACETOHEXAMIDE
002	TABLET;ORAL	250MG	0	DYMELOR	ACETOHEXAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1964-12-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1976-07-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1976-09-15	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1979-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1979-11-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1980-03-21	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1981-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1980-10-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-01-31	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1985-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1986-03-18	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1986-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1986-09-15	PRIORITY
LABELING; Labeling	SUPPL	28	AP	1987-01-30
LABELING; Labeling	SUPPL	29	AP	1988-12-29
LABELING; Labeling	SUPPL	30	AP	1990-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-06-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-10-19	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13378
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)