Last Updated: November 13, 2026

Details for New Drug Application (NDA): 204797

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NDA 204797 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms, 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 thirteen suppliers. Additional details are available on the ACETYLCYSTEINE profile page.

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

Summary for 204797

Tradename:	ACETYLCYSTEINE
Applicant:	Exela Pharma
Ingredient:	acetylcysteine
Patents:	0

Medical Subject Heading (MeSH) Categories for 204797

Antiviral Agents
Expectorants
Free Radical Scavengers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	6GM/30ML (200MG/ML)
Approval Date:	Apr 15, 2021	TE:		RLD:	No

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