Application 050596

Type
NDA
Sponsor
US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 20MG BASE/MLNoNo
002CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 20MG BASE/MLNoNo
003CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 40MG BASE/MLNoNo
004CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 40MG BASE/MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17915SUPPL2015-04-14
30142SUPPL2015-03-24
30141SUPPL2014-02-25
17914SUPPL2014-02-25
39023SUPPL2011-09-16
7867SUPPL2011-09-13
7866SUPPL2009-06-02
39022SUPPL2008-02-25
7865SUPPL2008-02-25
30140SUPPL2004-06-24
7864SUPPL2002-01-18