NDA 010669

ASPEN GLOBAL INC

FDA Drug Application

Application #010669

Documents

• Letter: 2001-07-24
• Letter: 2001-07-24
• Letter: 2003-11-25
• Letter: 2005-05-25
• Letter: 2010-04-28
• Letter: 2011-11-03
• Label: 2003-12-02
• Letter: 2001-07-24
• Letter: 2001-06-20
• Label: 2010-05-03
• Label: 2011-11-01

Application Sponsors

NDA 010669

ASPEN GLOBAL INC

Marketing Status

• Prescription: 002

Application Products

002

TABLET;ORAL

2MG

1

LEUKERAN

CHLORAMBUCIL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-03-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-03-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-02-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1978-03-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-06-08	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1981-08-27
LABELING; Labeling	SUPPL	11	AP	1984-03-12
LABELING; Labeling	SUPPL	12	AP	1986-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-03-06	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1989-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-10-14	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1996-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-02-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-06-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-07-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-07-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-07-24	PRIORITY
LABELING; Labeling	SUPPL	24	AP	2001-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-11-14	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2003-11-13	STANDARD
LABELING; Labeling	SUPPL	29	AP	2005-05-24	STANDARD
LABELING; Labeling	SUPPL	30	AP	2010-04-23	STANDARD
LABELING; Labeling	SUPPL	32	AP	2011-10-28	UNKNOWN

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	30	Null	6
SUPPL	32	Null	7

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10669
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUKERAN","activeIngredients":"CHLORAMBUCIL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/28\/2011","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/010669s032lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2010","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/010669s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/10669slr028_leukeran_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEUKERAN","submission":"CHLORAMBUCIL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-10-28
        )

)