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Details for New Drug Application (NDA): 202074

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NDA 202074 describes OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Sandoz, Teva Pharms, and Par Pharm, and is included in four NDAs. It is available from four suppliers. Additional details are available on the OLANZAPINE AND FLUOXETINE HYDROCHLORIDE profile page.

The generic ingredient in OLANZAPINE AND FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for NDA: 202074

Pharmacology for NDA: 202074

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 202074

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL 202074 ANDA Teva Pharmaceuticals USA, Inc. 0093-5503 0093-5503-56 30 CAPSULE in 1 BOTTLE (0093-5503-56)
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL 202074 ANDA AvKARE, Inc. 42291-652 42291-652-30 30 CAPSULE in 1 BOTTLE (42291-652-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 3MG BASE
Approval Date:Mar 25, 2013TE:ABRLD:No

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