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ACETYLCYSTEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2025-02-12

Drug application

FDA Application #

ANDA219194

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

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2025-02-12

Source

Authoritative

Drugs@FDA application overview

Machine

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