FDA.reportPublic FDA data

Application 076330

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6177Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6177Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6177Octreotide AcetateOctreotide AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6177Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6178Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6178Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6178Octreotide AcetateOctreotide AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6178Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent