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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072622

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NDA 072622 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 seven 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. Ten suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 072622
Tradename:ACETYLCYSTEINE
Applicant:Roxane
Ingredient:acetylcysteine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 072622

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Sep 30, 1992TE:RLD:No

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