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ACETADOTE

NDA · New Drug Application · Sponsor: CUMBERLAND PHARMS · Approved 2004-01-23

Drug application

FDA Application #

NDA021539

Application type

New Drug Application

Brand name

ACETADOTE

Generic name

ACETYLCYSTEINE

Active ingredients

ACETYLCYSTEINE

Dosage form

INJECTABLE

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

CUMBERLAND PHARMS

Manufacturer

Cumberland Pharmaceuticals Inc.

First approval

2004-01-23

Source

Authoritative

Drugs@FDA application overview

Machine

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