NDA 012429

ASPEN GLOBAL INC

FDA Drug Application

Application #012429

Documents

• Letter: 2003-07-06
• Label: 2003-07-08
• Label: 2003-12-29
• Label: 2004-11-16
• Letter: 2003-05-08
• Letter: 2003-12-24
• Letter: 2004-11-16
• Letter: 2018-05-24
• Label: 2018-05-25

Application Sponsors

NDA 012429

ASPEN GLOBAL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

40MG

1

THIOGUANINE

THIOGUANINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1966-01-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1977-02-11	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1978-08-24
LABELING; Labeling	SUPPL	8	AP	1984-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-08-06	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1985-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-07-18	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1986-09-22
LABELING; Labeling	SUPPL	13	AP	1987-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-04-05	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1991-07-15
LABELING; Labeling	SUPPL	17	AP	2001-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-07-03	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2003-06-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-12-19	STANDARD
LABELING; Labeling	SUPPL	22	AP	2004-11-15	STANDARD
LABELING; Labeling	SUPPL	28	AP	2018-05-23	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	28	Null	6

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12429
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOGUANINE","activeIngredients":"THIOGUANINE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/23\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/012429s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2004","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/12429s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/12429slr021_tabloid_lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2003","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/12429slr019_tabloid_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"THIOGUANINE","submission":"THIOGUANINE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-23
        )

)