← FDA Drug Approvals (Drugs@FDA)
SERTRALINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA · Approved 2026-01-20
Drug application
- FDA Application #
ANDA218342- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SERTRALINE HYDROCHLORIDE
- Generic name
- SERTRALINE HYDROCHLORIDE
- Active ingredients
- SERTRALINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- UMEDICA
- Manufacturer
- Biocon Pharma Inc.
- First approval
- 2026-01-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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