Details for New Drug Application (NDA): 077528
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NDA 077528 describes OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Endo Operations, Epic Pharma Llc, and Teva Pharms, and is included in four NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine 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. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 077528
| Tradename: | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
| Applicant: | Teva Pharms |
| Ingredient: | fluoxetine hydrochloride; olanzapine |
| Patents: | 0 |
Pharmacology for NDA: 077528
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 077528
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077528 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5504 | 0093-5504-56 | 30 CAPSULE in 1 BOTTLE (0093-5504-56) |
| OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077528 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5505 | 0093-5505-56 | 30 CAPSULE in 1 BOTTLE (0093-5505-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE;EQ 6MG BASE | ||||
| Approval Date: | Jun 19, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE;EQ 12MG BASE | ||||
| Approval Date: | Jun 19, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE;EQ 6MG BASE | ||||
| Approval Date: | Jun 19, 2012 | TE: | AB | RLD: | No | ||||
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