FDA Orange Book · active-ingredient family
Fluoxetine hydrochloride; olanzapine
Fluoxetine hydrochloride; olanzapine is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SYMBYAX · NDA 021520
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYMBYAXRLD×5 | LILLY | NDA 021520 | — | Apr 09, 2007 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | TEVA PHARMS | ANDA 202074 | AB | Mar 25, 2013 | |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE×5 | EPIC PHARMA LLC | ANDA 078901 | AB | Nov 16, 2012 | |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE×5 | PH HEALTH | ANDA 077742 | AB | Nov 02, 2012 | |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE×4 | TEVA PHARMS | ANDA 077528 | AB | Jun 19, 2012 |
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.
Fluoxetine hydrochloride; olanzapine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

