ABBVIE FDA Approval NDA 050775

NDA 050775

ABBVIE

FDA Drug Application

Application #050775

Documents

Letter2000-03-03
Letter2001-08-03
Letter2003-04-18
Letter2004-07-21
Letter2008-01-09
Letter2009-11-20
Letter2011-05-31
Letter2012-05-09
Letter2011-05-31
Letter2012-06-05
Letter2013-09-11
Letter2013-09-11
Letter2014-07-28
Label2009-09-22
Label2011-05-31
Label2012-07-10
Label2012-05-07
Label2013-09-09
Label2013-09-24
Label2016-06-01
Label2014-08-07
Label2015-01-12
Label2015-10-29
Review2001-11-23
Review2004-06-29
Letter2005-10-20
Letter2006-07-13
Letter2008-05-29
Letter2012-07-10
Letter2012-05-09
Letter2016-05-31
Letter2015-01-09
Letter2015-10-28
Label2000-03-03
Label2001-08-03
Label2005-10-10
Label2007-12-27
Label2012-05-07
Label2011-05-31
Review2001-10-11
Other Important Information from FDA2006-03-03
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 050775ABBVIE

Marketing Status

Discontinued001

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1BIAXIN XLCLARITHROMYCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2000-03-03STANDARD
LABELING; LabelingSUPPL2AP2002-03-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-11-16STANDARD
LABELING; LabelingSUPPL4AP2003-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-12-20STANDARD
LABELING; LabelingSUPPL7AP2004-07-19STANDARD
LABELING; LabelingSUPPL8AP2005-10-04STANDARD
LABELING; LabelingSUPPL9AP2006-07-05STANDARD
LABELING; LabelingSUPPL11AP2007-12-18STANDARD
LABELING; LabelingSUPPL12AP2008-05-22STANDARD
LABELING; LabelingSUPPL13AP2009-08-14STANDARD
LABELING; LabelingSUPPL14AP2011-05-27STANDARD
LABELING; LabelingSUPPL15AP2012-05-03STANDARD
LABELING; LabelingSUPPL16AP2011-05-27STANDARD
LABELING; LabelingSUPPL17AP2012-06-01STANDARD
LABELING; LabelingSUPPL18AP2012-07-05STANDARD
LABELING; LabelingSUPPL19AP2012-05-03STANDARD
LABELING; LabelingSUPPL20AP2013-09-09STANDARD
LABELING; LabelingSUPPL21AP2013-09-09STANDARD
LABELING; LabelingSUPPL22AP2016-05-26STANDARD
LABELING; LabelingSUPPL23AP2014-07-25STANDARD
LABELING; LabelingSUPPL24AP2015-01-08STANDARD
LABELING; LabelingSUPPL25AP2015-10-23STANDARD
LABELING; LabelingSUPPL26AP2017-06-09STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL27AP2018-11-25STANDARD
LABELING; LabelingSUPPL28AP2018-12-19STANDARD
LABELING; LabelingSUPPL29AP2019-09-18STANDARD
LABELING; LabelingSUPPL37AP2008-12-04STANDARD

Submissions Property Types

SUPPL3Null0
SUPPL5Null0
SUPPL7Null9
SUPPL13Null7
SUPPL14Null7
SUPPL15Null15
SUPPL16Null6
SUPPL17Null6
SUPPL18Null6
SUPPL19Null7
SUPPL20Null15
SUPPL21Null6
SUPPL22Null6
SUPPL23Null6
SUPPL24Null7
SUPPL25Null7
SUPPL26Null15
SUPPL27Null6
SUPPL28Null6
SUPPL29Null7
SUPPL37Null0

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50775
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIAXIN XL","activeIngredients":"CLARITHROMYCIN","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/18\/2019","submission":"SUPPL-29","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-28","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-27","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-26","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-22","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-25","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-24","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-23","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-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050775s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050775s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2012","submission":"SUPPL-18","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-19","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-15","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\/27\/2011","submission":"SUPPL-16","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-14","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-13","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-11","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-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050662s038,050698s020,050775s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2001","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50775s1lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/50775lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BIAXIN XL","submission":"CLARITHROMYCIN","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-09-18
        )

)
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