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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204674

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NDA 204674 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 204674

Tradename:	ACETYLCYSTEINE
Applicant:	Alvogen
Ingredient:	acetylcysteine
Patents:	0

Pharmacology for NDA: 204674

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

Medical Subject Heading (MeSH) Categories for 204674

Antiviral Agents
Expectorants
Free Radical Scavengers

Suppliers and Packaging for NDA: 204674

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	204674	ANDA	Fresenius Kabi USA, LLC	63323-691	63323-691-30	3 VIAL in 1 CARTON (63323-691-30) / 30 mL in 1 VIAL (63323-691-22)
ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	204674	ANDA	Fresenius Kabi USA, LLC	63323-693	63323-693-10	3 VIAL in 1 CARTON (63323-693-10) / 10 mL in 1 VIAL (63323-693-22)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION, ORAL			Strength	10%
Approval Date:	Feb 11, 2014	TE:	AN	RLD:	No

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