FDA.reportPublic FDA data

Application 077742

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 3MG BASENoNo
002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 6MG BASENoNo
003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 12MG BASENoNo
004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 6MG BASENoNo
005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 12MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22611ORIG2013-01-22
31285ORIG2012-12-18