Details for New Drug Application (NDA): 202074
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The generic ingredient in OLANZAPINE AND FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 202074
Tradename: | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
Applicant: | Teva Pharms |
Ingredient: | fluoxetine hydrochloride; olanzapine |
Patents: | 0 |
Pharmacology for NDA: 202074
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 202074
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 202074 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5503 | 0093-5503-56 | 30 CAPSULE in 1 BOTTLE (0093-5503-56) |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 202074 | ANDA | AvKARE | 42291-652 | 42291-652-30 | 30 CAPSULE in 1 BOTTLE (42291-652-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE;EQ 3MG BASE | ||||
Approval Date: | Mar 25, 2013 | TE: | AB | RLD: | No |
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