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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 203173

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NDA 203173 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 203173

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

Medical Subject Heading (MeSH) Categories for 203173

Antiviral Agents
Expectorants
Free Radical Scavengers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	6GM/30ML (200MG/ML)
Approval Date:	Mar 24, 2015	TE:	AP	RLD:	No

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