Application 090986

Type
ANDA
Sponsor
WOCKHARDT USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCTREOTIDE ACETATEOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.2MG BASE/MLNoNo
002OCTREOTIDE ACETATEOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 1MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-632Octreotide acetateOctreotide acetateWockhardt LimitedANDACurrent
55648-634Octreotide acetateOctreotide acetateWockhardt LimitedANDACurrent
64679-632Octreotide acetateOctreotide acetateWockhardt USA LLC.ANDACurrent
64679-634Octreotide acetateOctreotide acetateWockhardt USA LLC.ANDACurrent