NDA 050739

ABBVIE

FDA Drug Application

Application #050739

Documents

• Letter: 2002-07-24
• Letter: 2007-09-25
• Letter: 2008-12-19
• Label: 2005-07-21
• Label: 2007-06-27
• Label: 2015-11-19
• Letter: 1999-11-24
• Letter: 2004-09-03
• Letter: 2005-07-21
• Letter: 2007-07-05
• Letter: 2015-11-20
• Label: 1999-11-24
• Label: 2007-09-19
• Label: 2009-01-02
• Review: 2006-01-03

Application Sponsors

NDA 050739

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

OMNICEF

CEFDINIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-12-04	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1999-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-06-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2002-07-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-09-02	STANDARD
LABELING; Labeling	SUPPL	10	AP	2005-07-19	STANDARD
LABELING; Labeling	SUPPL	13	AP	2007-06-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2007-09-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	2008-12-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-11-18	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	17	Null	7

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50739
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMNICEF","activeIngredients":"CEFDINIR","strength":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/18\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050739s017,050749s023lbl.pdf\"}]","notes":"Please see"},{"actionDate":"12\/15\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050739s015,050749s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050739s014,050749s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2007","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050739s013,050749s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2005","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050739s010,050749s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/1999","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/50739S2LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMNICEF","submission":"CEFDINIR","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-11-18
        )

)