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ACETYLCYSTEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALVOGEN · Approved 2012-06-21

Drug application

FDA Application #

ANDA203853

Application type

Abbreviated New Drug Application (Generic)

Brand name

ACETYLCYSTEINE

Generic name

ACETYLCYSTEINE

Active ingredients

ACETYLCYSTEINE

Dosage form

SOLUTION

Route

INHALATION, ORAL

Marketing status

Prescription

Sponsor

ALVOGEN

Manufacturer

Fresenius Kabi USA, LLC

First approval

2012-06-21

Source

Authoritative

Drugs@FDA application overview

Machine

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