FDA.reportPublic FDA data

Application 078885

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUPROLIDE ACETATELEUPROLIDE ACETATEINJECTABLE;INJECTION1MG/0.2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-572leuprolide acetateleuprolide acetateNorthStar RxLLCANDACurrent
47335-936leuprolide acetateleuprolide acetateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-936leuprolide acetateleuprolide acetateSun Pharmaceutical Industries, Inc.ANDACurrent