NDA 013132

ASPEN GLOBAL INC

FDA Drug Application

Application #013132

Application Sponsors

NDA 013132

ASPEN GLOBAL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	50MG/ML	0	DECA-DURABOLIN	NANDROLONE DECANOATE
002	INJECTABLE;INJECTION	100MG/ML	0	DECA-DURABOLIN	NANDROLONE DECANOATE
003	INJECTABLE;INJECTION	200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DECA-DURABOLIN	NANDROLONE DECANOATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1962-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-12-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	1986-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1987-02-10	STANDARD
LABELING; Labeling	SUPPL	18	AP	1987-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-05-20	STANDARD

Submissions Property Types

SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13132
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECA-DURABOLIN","activeIngredients":"NANDROLONE DECANOATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DECA-DURABOLIN","activeIngredients":"NANDROLONE DECANOATE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DECA-DURABOLIN","activeIngredients":"NANDROLONE DECANOATE","strength":"200MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DECA-DURABOLIN","submission":"NANDROLONE DECANOATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DECA-DURABOLIN","submission":"NANDROLONE DECANOATE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DECA-DURABOLIN","submission":"NANDROLONE DECANOATE","actionType":"200MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)