FDA.reportPublic FDA data

Application 203649

Type
ANDA
Sponsor
SANDOZ INC

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
0781-3420TreprostiniltreprostinilSandoz IncANDACurrent
0781-3420TreprostiniltreprostinilSandoz IncANDACurrent
0781-3420TreprostiniltreprostinilSandoz IncANDACurrent
0781-3420TreprostiniltreprostinilSandoz IncANDACurrent
0781-3420TreprostiniltreprostinilSandoz IncANDACurrent
0781-3425TreprostiniltreprostinilSandoz IncANDACurrent
0781-3425TreprostiniltreprostinilSandoz IncANDACurrent
0781-3425TreprostiniltreprostinilSandoz IncANDACurrent
0781-3425TreprostiniltreprostinilSandoz IncANDACurrent
0781-3425TreprostiniltreprostinilSandoz IncANDACurrent
0781-3427TreprostiniltreprostinilSandoz IncANDACurrent
0781-3427TreprostiniltreprostinilSandoz IncANDACurrent
0781-3427TreprostiniltreprostinilSandoz IncANDACurrent
0781-3427TreprostiniltreprostinilSandoz IncANDACurrent
0781-3427TreprostiniltreprostinilSandoz IncANDACurrent
0781-3430TreprostiniltreprostinilSandoz IncANDACurrent
0781-3430TreprostiniltreprostinilSandoz IncANDACurrent
0781-3430TreprostiniltreprostinilSandoz IncANDACurrent
0781-3430TreprostiniltreprostinilSandoz IncANDACurrent
0781-3430TreprostiniltreprostinilSandoz IncANDACurrent
0781-6021DILUENTwater solutionSandoz IncANDACurrent
0781-6021DILUENTwater solutionSandoz IncANDACurrent
0781-6021DILUENTwater solutionSandoz IncANDACurrent
0781-6021DILUENTwater solutionSandoz IncANDACurrent
0781-6021DILUENTwater solutionSandoz IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50587ORIG2017-12-04
32455ORIG2014-11-04