FDA.reportPublic FDA data

Application 075957

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-3301Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3301Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3301Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3301Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3311Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3311Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3311Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3311Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3321Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3321Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3321Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-3321Octreotide AcetateOctreotide AcetateTeva Parenteral Medicines, Inc.ANDACurrent
63629-8831Octreotide AcetateOctreotide AcetateBryant Ranch PrepackANDACurrent
63629-8831Octreotide AcetateOctreotide AcetateBryant Ranch PrepackANDACurrent