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HYDROXYZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2025-04-28
Drug application
- FDA Application #
ANDA219289- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- HYDROXYZINE HYDROCHLORIDE
- Generic name
- HYDROXYZINE HYDROCHLORIDE ORAL
- Active ingredients
- HYDROXYZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BIONPHARMA
- Manufacturer
- Bionpharma Inc.
- First approval
- 2025-04-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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