FDA.reportPublic FDA data

Application 202074

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 3MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5503Olanzapine and FluoxetineOlanzapine and FluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-652Olanzapine and FluoxetineOlanzapine and FluoxetineAvKARE, Inc.ANDACurrent
42291-652Olanzapine and FluoxetineOlanzapine and FluoxetineAvKAREANDACurrent