Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078901
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| 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 |
|---|---|---|---|---|---|
| 04/25/2022 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2021 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/06/2021 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/06/2021 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/06/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 | 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 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 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 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 |
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 |