FDA.reportPublic FDA data

Application 050775

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIAXIN XLCLARITHROMYCINTABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60049SUPPL2019-09-19
60039SUPPL2019-09-19
56942SUPPL2018-12-31
56894SUPPL2018-12-20
56766SUPPL2018-12-18
56611SUPPL2018-11-30
48705SUPPL2017-06-12
48693SUPPL2017-06-12
18222SUPPL2016-06-01
30510SUPPL2016-05-31
18225SUPPL2015-10-29
30512SUPPL2015-10-28
18224SUPPL2015-01-12
30511SUPPL2015-01-09
18223SUPPL2014-08-07
8258SUPPL2014-07-28
18221SUPPL2013-09-24
8257SUPPL2013-09-11
8256SUPPL2013-09-11
18220SUPPL2013-09-09
30508SUPPL2012-07-10
18218SUPPL2012-07-10
8255SUPPL2012-06-05
30509SUPPL2012-05-09
8253SUPPL2012-05-09
39308SUPPL2012-05-07
18219SUPPL2012-05-07
39309SUPPL2011-05-31
18217SUPPL2011-05-31
8254SUPPL2011-05-31
8252SUPPL2011-05-31
8251SUPPL2009-11-20
18216SUPPL2009-09-22
30507SUPPL2008-05-29
8250SUPPL2008-01-09
39307SUPPL2007-12-27
30506SUPPL2006-07-13
44207ORIG2006-03-03
30505SUPPL2005-10-20
39306SUPPL2005-10-10
8249SUPPL2004-07-21
22232SUPPL2004-06-29
8248SUPPL2003-04-18
22231SUPPL2001-11-23
42731ORIG2001-10-11
39305SUPPL2001-08-03
8247SUPPL2001-08-03
39304ORIG2000-03-03
8246ORIG2000-03-03