ABBVIE FDA Approval NDA 050698

NDA 050698

ABBVIE

FDA Drug Application

Application #050698

Documents

Letter2002-05-24
Letter2004-07-21
Letter2005-10-20
Letter2006-07-13
Letter2008-05-29
Letter2009-11-20
Letter2011-05-31
Letter2012-07-10
Letter2012-05-09
Letter2013-09-11
Letter2015-01-09
Label2005-10-10
Label2007-12-27
Label2012-05-07
Label2012-07-10
Label2013-09-09
Label2013-09-09
Label2016-06-01
Label2015-10-29
Letter2008-01-09
Letter2011-05-31
Letter2012-05-09
Letter2012-06-05
Letter2013-09-11
Letter2016-05-31
Letter2014-07-28
Letter2015-10-28
Label2009-09-22
Label2011-05-31
Label2011-05-31
Label2012-05-07
Label2014-08-07
Label2015-01-12
Other Important Information from FDA2006-09-25
Label2017-06-12
Letter2017-06-12
Label2018-11-30
Letter2018-12-18
Label2018-12-20
Letter2018-12-31
Label2019-09-19
Letter2019-09-19

Application Sponsors

NDA 050698ABBVIE

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001FOR SUSPENSION;ORAL125MG/5ML1BIAXINCLARITHROMYCIN
002FOR SUSPENSION;ORAL250MG/5ML1BIAXINCLARITHROMYCIN
003FOR SUSPENSION;ORAL187MG/5ML0BIAXINCLARITHROMYCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1993-12-23STANDARD
EFFICACY; EfficacySUPPL2AP1994-08-12UNKNOWN
EFFICACY; EfficacySUPPL3AP1994-08-12UNKNOWN
EFFICACY; EfficacySUPPL4AP1994-08-12UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1994-03-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1995-10-23STANDARD
LABELING; LabelingSUPPL7AP1997-08-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1997-10-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-09-30STANDARD
LABELING; LabelingSUPPL11AP2000-06-05STANDARD
EFFICACY; EfficacySUPPL14AP2002-05-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-11-21STANDARD
LABELING; LabelingSUPPL19AP2004-07-19STANDARD
LABELING; LabelingSUPPL20AP2005-10-04STANDARD
LABELING; LabelingSUPPL21AP2006-07-05STANDARD
LABELING; LabelingSUPPL22AP2007-12-18STANDARD
LABELING; LabelingSUPPL23AP2008-05-22STANDARD
LABELING; LabelingSUPPL24AP2009-08-14STANDARD
LABELING; LabelingSUPPL25AP2011-05-27STANDARD
LABELING; LabelingSUPPL26AP2012-05-03STANDARD
LABELING; LabelingSUPPL27AP2011-05-27STANDARD
LABELING; LabelingSUPPL28AP2012-06-01STANDARD
LABELING; LabelingSUPPL29AP2012-07-05STANDARD
LABELING; LabelingSUPPL30AP2012-05-03STANDARD
LABELING; LabelingSUPPL31AP2013-09-09STANDARD
LABELING; LabelingSUPPL32AP2013-09-09STANDARD
LABELING; LabelingSUPPL33AP2016-05-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2013-10-24STANDARD
LABELING; LabelingSUPPL35AP2014-07-25STANDARD
LABELING; LabelingSUPPL36AP2015-01-08STANDARD
LABELING; LabelingSUPPL37AP2015-10-23STANDARD
LABELING; LabelingSUPPL38AP2017-06-09STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL39AP2018-11-25STANDARD
LABELING; LabelingSUPPL40AP2018-12-19STANDARD
LABELING; LabelingSUPPL41AP2019-09-18STANDARD

Submissions Property Types

ORIG1Null41
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL10Null0
SUPPL15Null0
SUPPL19Null9
SUPPL24Null7
SUPPL25Null7
SUPPL26Null15
SUPPL27Null6
SUPPL28Null6
SUPPL29Null7
SUPPL30Null7
SUPPL31Null15
SUPPL32Null6
SUPPL33Null6
SUPPL34Null0
SUPPL35Null15
SUPPL36Null6
SUPPL37Null7
SUPPL38Null7
SUPPL39Null15
SUPPL40Null6
SUPPL41Null6

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50698
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIAXIN","activeIngredients":"CLARITHROMYCIN","strength":"125MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BIAXIN","activeIngredients":"CLARITHROMYCIN","strength":"250MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BIAXIN","activeIngredients":"CLARITHROMYCIN","strength":"187MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/18\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050662s061,050698s041,050775s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050662s060,050698s040,050775s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2018","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050662s059,050698s039,050775s027lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050662s058,050698s038,050775s026lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/26\/2016","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050662s054,050698s033,050775s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050662s057,050698s037,050775s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2015","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050662s056lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2014","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050698s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050698s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050662s048,050698s029,050775s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050662s044s050,50698s026s030,050775s015s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2012","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050662s044s050,50698s026s030,050775s015s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2011","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050662s043s045,050698s025s027,050775s014s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2011","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050662s043s045,050698s025s027,050775s014s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2009","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050662s042,050698s024,050775s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2007","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050662s040,050698s022,050775s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2005","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050662s038,050698s020,050775s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BIAXIN","submission":"CLARITHROMYCIN","actionType":"125MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BIAXIN","submission":"CLARITHROMYCIN","actionType":"250MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BIAXIN","submission":"CLARITHROMYCIN","actionType":"187MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-09-18
        )

)
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