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SERTRALINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2026-01-20

Drug application

FDA Application #

ANDA219714

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

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2026-01-20

Source

Authoritative

Drugs@FDA application overview

Machine

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