FDA.reportPublic FDA data

Application 077528

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 6MG BASENoNo
002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 12MG BASENoNo
003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 6MG BASENoNo
004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 12MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5504Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5505Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5506Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5507Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-653Olanzapine and FluoxetineOlanzapine and FluoxetineAvKARE, Inc.ANDACurrent
42291-653Olanzapine and FluoxetineOlanzapine and FluoxetineAvKAREANDACurrent
42291-654Olanzapine and FluoxetineOlanzapine and FluoxetineAvKARE, Inc.ANDACurrent
42291-654Olanzapine and FluoxetineOlanzapine and FluoxetineAvKAREANDACurrent
42291-655Olanzapine and FluoxetineOlanzapine and FluoxetineAvKARE, Inc.ANDACurrent
42291-655Olanzapine and FluoxetineOlanzapine and FluoxetineAvKAREANDACurrent
42291-656Olanzapine and FluoxetineOlanzapine and FluoxetineAvKARE, Inc.ANDACurrent
42291-656Olanzapine and FluoxetineOlanzapine and FluoxetineAvKAREANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31258ORIG2012-06-22