← FDA Drug Approvals (Drugs@FDA)
QUETIAPINE FUMARATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2022-08-15
Drug application
- FDA Application #
ANDA215478- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- QUETIAPINE FUMARATE
- Generic name
- QUETIAPINE
- Active ingredients
- QUETIAPINE FUMARATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- UNICHEM
- Manufacturer
- BluePoint Laboratories
- First approval
- 2022-08-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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