FDA.reportPublic FDA data

Application 090656

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TORSEMIDETORSEMIDEINJECTABLE;INJECTION20MG/2ML (10MG/ML)NoNo
002TORSEMIDETORSEMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0770TorsemideTorsemideAmerican Regent, Inc.ANDACurrent
0517-0770TorsemideTorsemideAmerican Regent, Inc.ANDACurrent
0517-0771TorsemideTorsemideAmerican Regent, Inc.ANDACurrent
0517-0771TorsemideTorsemideAmerican Regent, Inc.ANDACurrent