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SERTRALINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2026-01-29

Drug application

FDA Application #
ANDA220275
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
ZYDUS LIFESCIENCES
Manufacturer
Zydus Pharmaceuticals (USA) Inc.
First approval
2026-01-29

Source

Authoritative
Drugs@FDA application overview
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