← FDA Drug Approvals (Drugs@FDA)
PAROXETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2025-09-24
Drug application
- FDA Application #
ANDA217280- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PAROXETINE HYDROCHLORIDE
- Generic name
- PAROXETINE
- Active ingredients
- PAROXETINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALEMBIC
- Manufacturer
- Alembic Pharmaceuticals Inc.
- First approval
- 2025-09-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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