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SERTRALINE HYDROCHLORIDE

NDA · New Drug Application · Sponsor: ALMATICA · Approved 2021-10-04

Drug application

FDA Application #

NDA215133

Application type

New Drug Application

Brand name

SERTRALINE HYDROCHLORIDE

Generic name

SERTRALINE HYDROCHLORIDE

Active ingredients

SERTRALINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ALMATICA

Manufacturer

Alvogen, Inc.

First approval

2021-10-04

Source

Authoritative

Drugs@FDA application overview

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