FDA.reportPublic FDA data

Application 050749

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMNICEFCEFDINIRFOR SUSPENSION;ORAL125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002OMNICEFCEFDINIRFOR SUSPENSION;ORAL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8173SUPPL2015-11-20
39243SUPPL2015-11-19
18169SUPPL2009-01-02
30438SUPPL2008-12-19
30437SUPPL2007-09-25
39242SUPPL2007-09-19
8172SUPPL2007-07-05
18168SUPPL2007-06-27
22216ORIG2006-01-03
39241SUPPL2005-07-21
8171SUPPL2005-07-21
30436SUPPL2004-09-03
8170SUPPL2004-07-30
30435SUPPL1999-07-14
18167SUPPL1999-07-14