Orange Book product · Brand (NDA)
SYMBYAX
FLUOXETINE HYDROCHLORIDE; OLANZAPINE
At a glance
Dec 24, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Strength
EQ 50MG BASE;EQ 12MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021520
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2013OLANZAPINE AND FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202074 · TEVA PHARMS
- 2012OLANZAPINE AND FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078901 · EPIC PHARMA LLC
- 2012OLANZAPINE AND FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077742 · PH HEALTH
- 2012OLANZAPINE AND FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077528 · TEVA PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
