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ACETYLCYSTEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AM REGENT · Approved 1995-07-28

Drug application

FDA Application #

ANDA072547

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

AM REGENT

Manufacturer

American Regent, Inc.

First approval

1995-07-28

Source

Authoritative

Drugs@FDA application overview

Machine

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