FDA.reportPublic FDA data

Application 076313

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.05MG BASE/MLNoYes
002OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.5MG BASE/MLNoYes
003OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.1MG BASE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6174Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6174Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6174Octreotide AcetateOctreotide AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6174Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6175Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6175Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6175Octreotide AcetateOctreotide AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6175Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6176Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6176Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6176Octreotide AcetateOctreotide AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6176Octreotide AcetateOctreotide AcetateHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31109ORIG2005-03-30