FDA.reportPublic FDA data

Application 019735

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLOXINOFLOXACINTABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002FLOXINOFLOXACINTABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
003FLOXINOFLOXACINTABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43624SUPPL2011-03-04
33903SUPPL2011-03-04
1565SUPPL2011-03-03
40992SUPPL2009-09-16
20312SUPPL2009-09-16
1564SUPPL2009-02-13
33902SUPPL2008-10-09
1563SUPPL2008-10-07
40991SUPPL2008-04-04
40990SUPPL2008-04-04
20311SUPPL2008-04-04
20310SUPPL2008-04-04
1562SUPPL2008-01-09
33901SUPPL2007-12-14
19138SUPPL2007-07-05
33900SUPPL2007-06-27
11667SUPPL2007-05-29
1561SUPPL2007-05-29
33899SUPPL2006-06-20
1560SUPPL2006-06-20
40989SUPPL2006-05-10
40988SUPPL2006-05-10
20309SUPPL2006-05-10
20308SUPPL2006-05-10
20307SUPPL2006-05-10
19137SUPPL2006-01-30
11666SUPPL2006-01-27
33898SUPPL2004-09-17
33897SUPPL2004-09-17
19136SUPPL2004-09-17
19135SUPPL2004-09-17
33896SUPPL2004-04-05
19134SUPPL2004-03-10