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OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2012-11-02
Drug application
- FDA Application #
ANDA077742- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
- Generic name
- OLANZAPINE AND FUOXETINE
- Active ingredients
- FLUOXETINE HYDROCHLORIDE; OLANZAPINE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PH HEALTH
- Manufacturer
- Par Health USA, LLC
- First approval
- 2012-11-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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