Assyro AI

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

ProductApplicantApplicationTEApproved
SYMBYAXRLD×5LILLYNDA 021520Apr 09, 2007

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
OLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMSANDA 202074ABMar 25, 2013
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE×5EPIC PHARMA LLCANDA 078901ABNov 16, 2012
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE×5PH HEALTHANDA 077742ABNov 02, 2012
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE×4TEVA PHARMSANDA 077528ABJun 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.

Agent CTA Background

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