← FDA Drug Approvals (Drugs@FDA)
FLUOXETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2008-01-31
Drug application
- FDA Application #
ANDA078619- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FLUOXETINE HYDROCHLORIDE
- Generic name
- FLUOXETINE HYDROCHLORIDE
- Active ingredients
- FLUOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AUROBINDO PHARMA
- Manufacturer
- QUALLENT PHARMACEUTICALS HEALTH LLC
- First approval
- 2008-01-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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