FDA.reportPublic FDA data

Application 020444

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLOLANEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 0.5MG BASE/VIALYesYes
002FLOLANEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 1.5MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0517FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0517FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0517FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0517FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0517FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0517FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0518DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0518DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0518DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0518DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0519FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0519FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0519FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0519FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0519FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0519FLOLANepoprostenol sodiumGlaxoSmithKline LLCNDACurrent
0173-0857DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0857DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0857DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0857DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0857DiluentwaterGlaxoSmithKline LLCNDACurrent
0173-0857DiluentwaterGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68470SUPPL2021-08-26
68468SUPPL2021-08-26
56876SUPPL2018-12-20
56739SUPPL2018-12-14
56121SUPPL2018-10-26
56093SUPPL2018-10-24
54244SUPPL2018-05-17
54211SUPPL2018-05-16
34656SUPPL2015-04-22
34655SUPPL2011-04-01
2538SUPPL2011-03-31
12581SUPPL2008-03-17
2537SUPPL2008-03-17
41367SUPPL2000-04-14
34654SUPPL2000-04-14
24970SUPPL2000-04-14
57467ORIG1995-09-20