NDA 020430

ASPEN GLOBAL INC

FDA Drug Application

Application #020430

Documents

• Letter: 2001-07-13
• Label: 2001-07-13
• Review: 2010-01-05
• Review: 2001-07-13

Application Sponsors

NDA 020430

ASPEN GLOBAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

750 UNITS/0.6ML

0

ORGARAN

DANAPAROID SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-12-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	1998-01-30	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2001-06-26	STANDARD

Submissions Property Types

SUPPL

1

Null

0

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20430
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORGARAN","activeIngredients":"DANAPAROID SODIUM","strength":"750 UNITS\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/26\/2001","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-430S003_Orgaran_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORGARAN","submission":"DANAPAROID SODIUM","actionType":"750 UNITS\/0.6ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-06-26
        )

)