FDA.reportPublic FDA data

Application 050662

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIAXINCLARITHROMYCINTABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002BIAXINCLARITHROMYCINTABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
60047SUPPL2019-09-19
60037SUPPL2019-09-19
56940SUPPL2018-12-31
56892SUPPL2018-12-20
56765SUPPL2018-12-18
56561SUPPL2018-11-26
48703SUPPL2017-06-12
48691SUPPL2017-06-12
39079SUPPL2016-06-01
7952SUPPL2016-05-31
17992SUPPL2015-10-29
30245SUPPL2015-10-28
17991SUPPL2015-01-12
7954SUPPL2015-01-09
39080SUPPL2014-08-07
7953SUPPL2014-07-28
30244SUPPL2013-09-11
7951SUPPL2013-09-11
17990SUPPL2013-09-09
17989SUPPL2013-09-09
30243SUPPL2012-07-10
17988SUPPL2012-07-10
7949SUPPL2012-06-05
7950SUPPL2012-05-09
7947SUPPL2012-05-09
39078SUPPL2012-05-07
17986SUPPL2012-05-07
39077SUPPL2011-05-31
30242SUPPL2011-05-31
17987SUPPL2011-05-31
7948SUPPL2011-05-31
30241SUPPL2009-11-20
17985SUPPL2009-09-22
30240SUPPL2008-05-29
30239SUPPL2008-01-09
17984SUPPL2007-12-27
30238SUPPL2006-07-13
44201ORIG2006-03-03
30237SUPPL2005-10-20
39076SUPPL2005-10-10
30236SUPPL2004-07-21
42666SUPPL2004-06-29
22174SUPPL2004-06-29
22173SUPPL2004-06-29
30235SUPPL2002-06-06
7946SUPPL2002-06-06
42667SUPPL2001-11-23
30234SUPPL2000-10-20
17983SUPPL2000-10-20
42665SUPPL1999-08-02