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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 208166

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NDA 208166 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 208166

Tradename:	ACETYLCYSTEINE
Applicant:	Zydus Pharms
Ingredient:	acetylcysteine
Patents:	0

Medical Subject Heading (MeSH) Categories for 208166

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:	Jul 20, 2018	TE:	AP	RLD:	No

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