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Harvard Business School
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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203853

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NDA 203853 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 203853
Applicant:Alvogen Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 203853
Medical Subject Heading (MeSH) Categories for 203853
Suppliers and Packaging for NDA: 203853
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 203853 ANDA Fresenius Kabi USA, LLC 63323-690 N 63323-690-30
ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 203853 ANDA Fresenius Kabi USA, LLC 63323-692 N 63323-692-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, ORALStrength20%
Approval Date:Jun 21, 2012TE:ANRLD:No

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