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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 072547

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NDA 072547 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Onesource Specialty, Regcon Holdings, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Zydus Pharms, Alvogen, Am Regent, Conba Usa, Hospira, and Roxane, and is included in twenty-five NDAs. It is available from twelve suppliers. Additional details are available on the ACETYLCYSTEINE profile page.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 072547

Tradename:	ACETYLCYSTEINE
Applicant:	Am Regent
Ingredient:	acetylcysteine
Patents:	0

Pharmacology for NDA: 072547

Mechanism of Action	Reduction Activity
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration

Medical Subject Heading (MeSH) Categories for 072547

Antiviral Agents
Expectorants
Free Radical Scavengers

Suppliers and Packaging for NDA: 072547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	072547	ANDA	American Regent, Inc.	0517-7604	0517-7604-25	25 VIAL, GLASS in 1 TRAY (0517-7604-25) / 4 mL in 1 VIAL, GLASS
ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	072547	ANDA	American Regent, Inc.	0517-7610	0517-7610-03	3 VIAL, GLASS in 1 BOX (0517-7610-03) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION, ORAL			Strength	20%
Approval Date:	Jul 28, 1995	TE:	AN	RLD:	No

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