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Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203624

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NDA 203624 describes ACETYLCYSTEINE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms, Alvogen Inc, Hospira, Luitpold, and Roxane, and is included in seventeen NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 203624

Tradename:	ACETYLCYSTEINE
Applicant:	Mylan Institutional
Ingredient:	acetylcysteine
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 203624

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:	Jun 19, 2015	TE:	AP	RLD:	No

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