Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078901
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription AB No No
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription AB No No
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription AB No No
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription AB No No
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/16/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078901Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/07/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/07/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/14/2015 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/14/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/14/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/18/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 25MG BASE;EQ 6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 077528 TEVA PHARMS
SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription Yes AB 021520 LILLY

CAPSULE;ORAL; EQ 50MG BASE;EQ 6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription No AB 077528 TEVA PHARMS
SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE;ORAL Prescription Yes AB 021520 LILLY

CAPSULE;ORAL; EQ 25MG BASE;EQ 12MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 077528 TEVA PHARMS
SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription Yes AB 021520 LILLY

CAPSULE;ORAL; EQ 50MG BASE;EQ 12MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription No AB 077528 TEVA PHARMS
SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE;ORAL Prescription Yes AB 021520 LILLY

CAPSULE;ORAL; EQ 25MG BASE;EQ 3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE;ORAL Prescription No AB 077742 PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE;ORAL Prescription No AB 078901 SANDOZ
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE;ORAL Prescription No AB 202074 TEVA PHARMS
SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE;ORAL Prescription Yes AB 021520 LILLY

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