Drugs@FDA: FDA-Approved Drugs
Company: ENDO OPERATIONS
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 3MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
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 25MG BASE;EQ 12MG 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 50MG BASE;EQ 12MG 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 |
---|---|---|---|---|---|---|---|
11/02/2012 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077742Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077742Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/16/2024 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/01/2023 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2021 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2021 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/05/2015 | SUPPL-9 | Labeling-Medication Guide |
Label is not available on this site. |
||
03/14/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
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 | ENDO OPERATIONS |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 3MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
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 |
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 | ENDO OPERATIONS |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
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 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 | ENDO OPERATIONS |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
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 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 | ENDO OPERATIONS |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
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 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 | ENDO OPERATIONS |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078901 | EPIC PHARMA LLC |
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 |