← FDA Drug Approvals (Drugs@FDA)
PAROXETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2021-09-03
Drug application
- FDA Application #
ANDA215003- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PAROXETINE HYDROCHLORIDE
- Generic name
- PAROXETINE
- Active ingredients
- PAROXETINE HYDROCHLORIDE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NOVITIUM PHARMA
- Manufacturer
- ANI Pharmaceuticals, Inc.
- First approval
- 2021-09-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown