NDA 006695

RECORDATI RARE

FDA Drug Application

Application #006695

Documents

• Letter: 2003-03-26
• Letter: 2004-03-02
• Label: 2004-04-05

Application Sponsors

NDA 006695

RECORDATI RARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/VIAL

1

MUSTARGEN

MECHLORETHAMINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1949-03-15	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1978-06-12
LABELING; Labeling	SUPPL	14	AP	1980-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-03-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1983-02-21	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1986-03-29
LABELING; Labeling	SUPPL	19	AP	1987-01-15
LABELING; Labeling	SUPPL	20	AP	1987-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-01-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-10-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1995-03-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1995-04-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1995-12-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-10-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-10-16	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2000-03-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2000-11-17	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2003-03-19	STANDARD
LABELING; Labeling	SUPPL	31	AP	2004-02-09	STANDARD

Submissions Property Types

SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0

CDER Filings

RECORDATI RARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6695
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MUSTARGEN","activeIngredients":"MECHLORETHAMINE HYDROCHLORIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/09\/2004","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/06695slr031_mustargen_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MUSTARGEN","submission":"MECHLORETHAMINE HYDROCHLORIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-02-09
        )

)