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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 071364

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NDA 071364 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 071364

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

Medical Subject Heading (MeSH) Categories for 071364

Antiviral Agents
Expectorants
Free Radical Scavengers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION, ORAL			Strength	10%
Approval Date:	May 1, 1989	TE:		RLD:	No

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