← FDA Drug Approvals (Drugs@FDA)
SERTRALINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2021-05-03
Drug application
- FDA Application #
ANDA214790- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SERTRALINE HYDROCHLORIDE
- Generic name
- SERTRALINE HYDROCHLORIDE
- Active ingredients
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ASCENT PHARMS INC
- Manufacturer
- XLCare Pharmaceuticals, Inc.
- First approval
- 2021-05-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown