FDA.reportPublic FDA data

Application 206648

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREPROSTINILTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS1MG/MLNoNo
002TREPROSTINILTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS2.5MG/MLNoNo
003TREPROSTINILTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS5MG/MLNoNo
004TREPROSTINILTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-0666TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0666TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0666TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0676TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0676TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0676TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0686TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0686TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0686TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0696TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0696TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent
0703-0696TreprostinilTreprostinilTeva Parenteral Medicines, Inc.ANDACurrent