← FDA Drug Approvals (Drugs@FDA)
FLUVOXAMINE MALEATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2013-03-13
Drug application
- FDA Application #
ANDA091476
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FLUVOXAMINE MALEATE
- Generic name
- FLUVOXAMINE MALEATE
- Active ingredients
- FLUVOXAMINE MALEATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PH HEALTH
- Manufacturer
- Endo USA, Inc.
- First approval
- 2013-03-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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