NDA 012674

ASPEN GLOBAL INC

FDA Drug Application

Application #012674

Application Sponsors

NDA 012674

ASPEN GLOBAL INC

Marketing Status

• Discontinued: 001

Application Products

001

ELIXIR;ORAL

0.5MG/5ML

0

HEXADROL

DEXAMETHASONE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1960-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-06-02	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12674
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE","strength":"0.5MG\/5ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HEXADROL","submission":"DEXAMETHASONE","actionType":"0.5MG\/5ML","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)