NDA 016785

LEADIANT BIOSCI INC

FDA Drug Application

Application #016785

Documents

• Letter: 2003-01-29

Application Sponsors

NDA 016785

LEADIANT BIOSCI INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 50MG BASE

1

MATULANE

PROCARBAZINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1969-07-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1976-04-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1977-05-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1978-11-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1979-01-09	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1980-03-24
LABELING; Labeling	SUPPL	19	AP	1981-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1979-11-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1980-07-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1981-03-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1981-12-18	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1986-04-29
LABELING; Labeling	SUPPL	26	AP	1987-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1987-03-05	PRIORITY
LABELING; Labeling	SUPPL	28	AP	1986-05-07
LABELING; Labeling	SUPPL	29	AP	1987-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-10-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1999-03-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2001-03-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2001-11-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-03-13	PRIORITY
LABELING; Labeling	SUPPL	35	AP	2002-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2016-02-02	PRIORITY

Submissions Property Types

SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	39	Null	0

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16785
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MATULANE","activeIngredients":"PROCARBAZINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MATULANE","submission":"PROCARBAZINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)