FDA.reportPublic FDA data

Application 091041

Type
ANDA
Sponsor
SAGENT PHARMS INC

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
25021-454Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-454Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-454Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-454Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-455Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-455Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-455Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-455Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-466Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-467Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent