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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 071365

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NDA 071365 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in twenty-three NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 071365

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

Medical Subject Heading (MeSH) Categories for 071365

Antiviral Agents
Expectorants
Free Radical Scavengers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION, ORAL			Strength	20%
Approval Date:	May 1, 1989	TE:		RLD:	No

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