FDA.reportPublic FDA data

Application 078396

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPOPROSTENOL SODIUMEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 0.5MG BASE/VIALNoNo
002EPOPROSTENOL SODIUMEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 1.5MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-1985Epoprostenol SodiumEpoprostenol SodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-1985Epoprostenol SodiumEpoprostenol SodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-1985Epoprostenol SodiumEpoprostenol SodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-1995Epoprostenol SodiumEpoprostenol SodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-1995Epoprostenol SodiumEpoprostenol SodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-1995Epoprostenol SodiumEpoprostenol SodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-9258Sterile DiluentSterile DiluentTeva Parenteral Medicines, Inc.ANDACurrent
0703-9258Sterile DiluentSterile DiluentTeva Parenteral Medicines, Inc.ANDACurrent
0703-9258Sterile DiluentSterile DiluentTeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9154ORIG2008-04-28