FDA.reportPublic FDA data

Application 090985

Type
ANDA
Sponsor
WOCKHARDT USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCTREOTIDE ACETATE PRESERVATIVE FREEOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.05MG BASE/MLNoNo
002OCTREOTIDE ACETATE PRESERVATIVE FREEOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.1MG BASE/MLNoNo
003OCTREOTIDE ACETATE PRESERVATIVE FREEOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.5MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-633Octreotide acetateOctreotide acetateWockhardt LimitedANDACurrent
55648-635Octreotide acetateOctreotide acetateWockhardt LimitedANDACurrent
55648-636Octreotide acetateOctreotide acetateWockhardt LimitedANDACurrent
64679-633Octreotide acetateOctreotide acetateWockhardt USA LLC.ANDACurrent
64679-635Octreotide acetateOctreotide acetateWockhardt USA LLC.ANDACurrent
64679-636Octreotide acetateOctreotide acetateWockhardt USA LLC.ANDACurrent