FDA.reportPublic FDA data

Application 021569

Type
NDA
Sponsor
LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION405MG/50ML (9MG/ML)YesNo
002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION1012.5MG/125ML (9MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0019-1188SODIUM CHLORIDEsodium chlorideLiebel-Flarsheim Company LLCNDACurrent
0019-1188SODIUM CHLORIDEsodium chlorideLiebel-Flarsheim Company LLCNDACurrent
0019-1188SODIUM CHLORIDEsodium chlorideLiebel-Flarsheim Company LLCNDACurrent
0019-1188SODIUM CHLORIDEsodium chlorideLiebel-Flarsheim Company LLCNDACurrent
0019-1188SODIUM CHLORIDEsodium chlorideLiebel-Flarsheim Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57109SUPPL2019-01-03
57097SUPPL2019-01-02
5754SUPPL2012-03-12
15794SUPPL2012-03-06
37249SUPPL2009-10-16
37248SUPPL2008-06-12
5753SUPPL2008-04-30
21738ORIG2007-09-11
37247ORIG2006-08-04
5752ORIG2006-08-04