NDA 012675

ASPEN GLOBAL INC

FDA Drug Application

Application #012675

Application Sponsors

NDA 012675

ASPEN GLOBAL INC

Marketing Status

• Discontinued: 004
• Discontinued: 007
• Discontinued: 009
• Discontinued: 010

Application Products

004	TABLET;ORAL	0.5MG	0	HEXADROL	DEXAMETHASONE
007	TABLET;ORAL	0.75MG	0	HEXADROL	DEXAMETHASONE
009	TABLET;ORAL	1.5MG	0	HEXADROL	DEXAMETHASONE
010	TABLET;ORAL	4MG	0	HEXADROL	DEXAMETHASONE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1962-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-04-26	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12675
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HEXADROL","submission":"DEXAMETHASONE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEXADROL","submission":"DEXAMETHASONE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEXADROL","submission":"DEXAMETHASONE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEXADROL","submission":"DEXAMETHASONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)