NDA 020484

LEO PHARMA AS

FDA Drug Application

Application #020484

Documents

• Letter: 2000-07-14
• Letter: 2004-06-07
• Letter: 2008-12-30
• Label: 2000-07-14
• Label: 2009-12-30
• Label: 2010-10-12
• Review: 2000-07-14
• Letter: 2002-02-05
• Letter: 2006-11-09
• Letter: 2009-12-31
• Letter: 2010-10-13
• Label: 2009-01-02

Application Sponsors

NDA 020484

LEO PHARMA AS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

20,000 IU/ML

0

INNOHEP

TINZAPARIN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2000-07-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2002-02-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2003-03-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2006-11-07	STANDARD
LABELING; Labeling	SUPPL	11	AP	2008-12-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2009-12-23	STANDARD
LABELING; Labeling	SUPPL	14	AP	2010-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20484
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"INNOHEP","activeIngredients":"TINZAPARIN SODIUM","strength":"20,000 IU\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2010","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020484s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2009","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020484s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2008","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020484s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20484lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INNOHEP","submission":"TINZAPARIN SODIUM","actionType":"20,000 IU\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-10-07
        )

)